Diffuse Large B Cell Lymphoma Clinical Trial
— RE-MIND2Official title:
An Observational Retrospective Cohort Study of Systemic Therapies for Relapsed or Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL), to Compare Outcomes to Those From Tafasitamab + Lenalidomide in the L-MIND Study
| NCT number | NCT04697160 |
| Other study ID # | MOR208C213 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2020 |
| Est. completion date | May 7, 2021 |
| Verified date | October 2021 |
| Source | MorphoSys AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
To compare the efficacy outcomes of the L-MIND cohort with the effectiveness in a matched patient population treated with systemic NCCN/ESMO guideline listed regimens administered in routine clinical care.
| Status | Completed |
| Enrollment | 3573 |
| Est. completion date | May 7, 2021 |
| Est. primary completion date | May 7, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Eligibility Criteria: 1. Age = 18 years at the initial DLBCL diagnosis. 2. One of the following histologically confirmed diagnosis: DLBCL not otherwise specified (NOS); T-cell/histiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma (FL), Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as FL, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL with a subsequent DLBCL relapse are also eligible. 3. Relapsed or refractory DLBCL and received at least 2 systemic regimens for the treatment of DLBCL, including at least 1 anti-CD20 containing therapy. Non-Eligibility Criteria: 1. Patients with central nervous system (CNS) involvement by lymphoma at initial DLBCL diagnosis. 2. Patients who were treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs) (e.g., thalidomide, LEN) as a frontline DLBCL therapy. 3. Patients who underwent an allogeneic stem cell transplant. 4. Patients who had a prior history of malignancies other than DLBCL, unless the patient has been free of the disease for =5 years prior to inclusion. Note: Patients with the following malignancies within the 5 years period are still eligible: 1. basal cell carcinoma of the skin 2. squamous cell carcinoma of the skin 3. carcinoma in situ of the cervix 4. carcinoma in situ of the breast 5. carcinoma in situ of the bladder 6. incidental histological finding of prostate cancer (Tumor/Node/Metastasis [TNM] stage of T1a or T1b) 5. Patients who received tafasitamab. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | MorphoSys Research Site | Adelaide | |
| Australia | MorphoSys Research Site | Benowa | |
| Australia | MorphoSys Research Site | Concord | |
| Australia | MorphoSys Research Site | Darlinghurst | |
| Australia | MorphoSys Research Site | East Melbourne | |
| Australia | MorphoSys Research Site | Fitzroy | |
| Australia | MorphoSys Research Site | Frankston | |
| Australia | MorphoSys Research Site | Kingswood | |
| Australia | MorphoSys Research Site | Nedlands | |
| Austria | MorphoSys Research Site | Leoben | |
| Austria | MorphoSys Research Site | Linz | |
| Austria | MorphoSys Research Site | Salzburg | |
| Austria | MorphoSys Research Site | Sankt Pölten | |
| Austria | MorphoSys Research Site | Wels | |
| Austria | MorphoSys Research Site | Wien | |
| Canada | MorphoSys Research Site | Edmonton | |
| Canada | MorphoSys Research Site | Montréal | |
| Denmark | MorphoSys Research Site | Aalborg | |
| France | MorphoSys Research Site | Albi | |
| France | MorphoSys Research Site | Amiens | |
| France | MorphoSys Research Site | Angers | |
| France | MorphoSys Research Site | Caen | |
| France | MorphoSys Research Site | Carcassonne | |
| France | MorphoSys Research Site | Castres | |
| France | MorphoSys Research Site | Chambéry | |
| France | MorphoSys Research Site | Grenoble | |
| France | MorphoSys Research Site | La Roche-sur-Yon | |
| France | MorphoSys Research Site | Lille | |
| France | MorphoSys Research Site | Montpellier | |
| France | MorphoSys Research Site | Narbonne | |
| France | MorphoSys Research Site | Nice | |
| France | MorphoSys Research Site | Nîmes | |
| France | MorphoSys Research Site | Orléans | |
| France | MorphoSys Research Site | Paris | |
| France | MorphoSys Research Site | Paris | |
| France | MorphoSys Research Site | Perpignan | |
| France | MorphoSys Research Site | Pessac | |
| France | MorphoSys Research Site | Pierre-Bénite | |
| France | MorphoSys Research Site | Quimper | |
| France | MorphoSys Research Site | Rodez | |
| France | MorphoSys Research Site | Rouen | |
| France | MorphoSys Research Site | Saint-Brieuc | |
| France | MorphoSys Research Site | Saint-Priest-en-Jarez | |
| France | MorphoSys Research Site | Saint-Quentin | |
| France | MorphoSys Research Site | Toulouse | |
| France | MorphoSys Research Site | Tours | |
| France | MorphoSys Research Site | Troyes | |
| France | MorphoSys Research Site | Vandœuvre-lès-Nancy | |
| Germany | MorphoSys Research Site | Aschaffenburg | |
| Germany | MorphoSys Research Site | Augsburg | |
| Germany | MorphoSys Research Site | Bad Liebenwerda | |
| Germany | MorphoSys Research Site | Donauwörth | |
| Germany | MorphoSys Research Site | Dresden | |
| Germany | MorphoSys Research Site | Dresden | |
| Germany | MorphoSys Research Site | Flensburg | |
| Germany | MorphoSys Research Site | Frechen | |
| Germany | MorphoSys Research Site | Freiburg im Breisgau | |
| Germany | MorphoSys Research Site | Göttingen | |
| Germany | MorphoSys Research Site | Halle | |
| Germany | MorphoSys Research Site | Hamburg | |
| Germany | MorphoSys Research Site | Hannover | |
| Germany | MorphoSys Research Site | Hannover | |
| Germany | MorphoSys Research Site | Heidelberg | |
| Germany | MorphoSys Research Site | Heilbronn | |
| Germany | MorphoSys Research Site | Köln | |
| Germany | MorphoSys Research Site | Landshut | |
| Germany | MorphoSys Research Site | Lebach | |
| Germany | MorphoSys Research Site | Lübeck | |
| Germany | MorphoSys Research Site | Mainz | |
| Germany | MorphoSys Research Site | Münster | |
| Germany | MorphoSys Research Site | Neustadt | |
| Germany | MorphoSys Research Site | Oldenburg | |
| Germany | MorphoSys Research Site | Oldenburg In Holstein | |
| Germany | MorphoSys Research Site | Potsdam | |
| Germany | MorphoSys Research Site | Ratingen | |
| Germany | MorphoSys Research Site | Saarbrücken | |
| Germany | MorphoSys Research Site | Schorndorf | |
| Germany | MorphoSys Research Site | Stuttgart | |
| Germany | MorphoSys Research Site | Villingen Schwenningen | |
| Germany | MorphoSys Research Site | Villingen-Schwenningen | |
| Germany | MorphoSys Research Site | Wilhelmshaven | |
| Germany | MorphoSys Research Site | Wolfsburg | |
| Italy | MorphoSys Research Site | Alessandria | |
| Italy | MorphoSys Research Site | Ancona | |
| Italy | MorphoSys Research Site | Aviano | |
| Italy | MorphoSys Research Site | Bergamo | |
| Italy | MorphoSys Research Site | Bologna | |
| Italy | MorphoSys Research Site | Como | |
| Italy | MorphoSys Research Site | Cremona | |
| Italy | MorphoSys Research Site | Firenze | |
| Italy | MorphoSys Research Site | Lecce | |
| Italy | MorphoSys Research Site | Milano | |
| Italy | MorphoSys Research Site | Modena | |
| Italy | MorphoSys Research Site | Napoli | |
| Italy | MorphoSys Research Site | Palermo | |
| Italy | MorphoSys Research Site | Perugia | |
| Italy | MorphoSys Research Site | Piacenza | |
| Italy | MorphoSys Research Site | Ponderano | |
| Italy | MorphoSys Research Site | Ravenna | |
| Italy | MorphoSys Research Site | Reggio Calabria | |
| Italy | MorphoSys Research Site | Rimini | |
| Italy | MorphoSys Research Site | Roma | |
| Italy | MorphoSys Research Site | Roma | |
| Italy | MorphoSys Research Site | Roma | |
| Italy | MorphoSys Research Site | Terni | |
| Italy | MorphoSys Research Site | Udine | |
| Italy | MorphoSys Research Site | Vicenza | |
| Korea, Republic of | MorphoSys Research Site | Busan | |
| Korea, Republic of | MorphoSys Research Site | Busan | |
| Korea, Republic of | MorphoSys Research Site | Seoul | |
| Korea, Republic of | MorphoSys Research Site | Seoul | |
| Korea, Republic of | MorphoSys Research Site | Seoul | |
| Korea, Republic of | MorphoSys Research Site | Ulsan | |
| Spain | MorphoSys Research Site | Badalona | |
| Spain | MorphoSys Research Site | Barcelona | |
| Spain | MorphoSys Research Site | Hospitalet de Llobregat | |
| Spain | MorphoSys Research Site | Lugo | |
| Spain | MorphoSys Research Site | Madrid | |
| Spain | MorphoSys Research Site | Madrid | |
| Spain | MorphoSys Research Site | Madrid | |
| Spain | MorphoSys Research Site | Madrid | |
| Spain | MorphoSys Research Site | Madrid | |
| Spain | MorphoSys Research Site | Majadahonda | |
| Spain | MorphoSys Research Site | Palma De Mallorca | |
| Spain | MorphoSys Research Site | Palma De Mallorca | |
| Spain | MorphoSys Research Site | Pamplona | |
| Spain | MorphoSys Research Site | Pozuelo De Alarcón | |
| Spain | MorphoSys Research Site | Sabadell | |
| Spain | MorphoSys Research Site | Salamanca | |
| Spain | MorphoSys Research Site | Santander | |
| Spain | MorphoSys Research Site | Sevilla | |
| Spain | MorphoSys Research Site | Valencia | |
| Spain | MorphoSys Research Site | Valencia | |
| Spain | MorphoSys Research Site | Valladolid | |
| Spain | MorphoSys Research Site | Valladolid | |
| Taiwan | MorphoSys Research Site | Taichung | |
| Taiwan | MorphoSys Research Site | Tainan | |
| Taiwan | MorphoSys Research Site | Taipei city | |
| United Kingdom | MorphoSys Research Site | Brighton | |
| United Kingdom | MorphoSys Research Site | Manchester | |
| United Kingdom | MorphoSys Research Site | Sunderland | |
| United Kingdom | MorphoSys Research Site | Taunton | |
| United Kingdom | MorphoSys Research Site | Truro | |
| United Kingdom | MorphoSys Research Site | Westcliff-on-Sea | |
| United States | MorphoSys Research Site | Ann Arbor | Michigan |
| United States | MorphoSys Research Site | Broomfield | Colorado |
| United States | MorphoSys Research Site | Charlotte | North Carolina |
| United States | MorphoSys Research Site | Chicago | Illinois |
| United States | MorphoSys Research Site | Clovis | California |
| United States | MorphoSys Research Site | Indianapolis | Indiana |
| United States | MorphoSys Research Site | Jackson | Mississippi |
| United States | MorphoSys Research Site | Los Angeles | California |
| United States | MorphoSys Research Site | Minneapolis | Minnesota |
| United States | MorphoSys Research Site | Morristown | New Jersey |
| United States | MorphoSys Research Site | Nashville | Tennessee |
| United States | MorphoSys Research Site | New York | New York |
| United States | MorphoSys Research Site | New York | New York |
| United States | MorphoSys Research Site | Orange | California |
| United States | MorphoSys Research Site | Portland | Oregon |
| United States | MorphoSys Research Site | Rochester | Minnesota |
| United States | MorphoSys Research Site | Salt Lake City | Utah |
| United States | MorphoSys Research Site | Scottsdale | Arizona |
| United States | MorphoSys Research Site | Skokie | Illinois |
| United States | MorphoSys Research Site | Spokane | Washington |
| United States | MorphoSys Research Site | Torrance | California |
| United States | MorphoSys Research Site | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| MorphoSys AG |
United States, Australia, Austria, Canada, Denmark, France, Germany, Italy, Korea, Republic of, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) | through study completion, an average of 1 year | ||
| Secondary | Overall/Objective Response Rate (ORR) | through study completion, an average of 1 year | ||
| Secondary | Complete Response Rate (CR) | through study completion, an average of 1 year | ||
| Secondary | Duration of Response (DoR) | through study completion, an average of 1 year | ||
| Secondary | Event Free Survival (EFS) | through study completion, an average of 1 year | ||
| Secondary | Progression Free Survival (PFS) | through study completion, an average of 1 year | ||
| Secondary | Time to next treatment (TTNT) | through study completion, an average of 1 year | ||
| Secondary | Treatment discontinuation rate due to adverse events | through study completion, an average of 1 year | ||
| Secondary | Duration of treatment exposure | through study completion, an average of 1 year |
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