Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01182415
Other study ID # 09-444
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2010
Est. completion date December 2016

Study information

Verified date March 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Current standard treatments for lymphoma involving the central nervous system include chemotherapy or whole brain radiation therapy (WBRT). However, many patients do not respond to this treatment, and some of the patients who do respond relapse after treatment. Previous research has shown that a stem cell transplant of a patient's own cells (autologous stem cell transplant) may be more effective for some patients with lymphoma involving the CNS. In previous research using autologous stem cell transplants for lymphoma involving the CNS, a conditioning regimen consisting of the drugs thiotepa, busulfan and cyclophosphamide (TCE) was used. These drugs have been shown to enter the nervous system. In this research study, the investigators are adding the drug rituximab (Rituxan) to the drug cytarabine for the stem cell mobilization process. Cytarabine is a standard drug for mobilization. In addition, rituximab will be added to the conditioning regimen of thiotepa, busulfan and cyclophosphamide. Rituximab is approved by the FDA for the treatment of some types of lymphomas, but is not approved for use in lymphomas that involve the CNS. Rituximab is known to be able to enter the CNS. Previous research has suggested that it may help treat lymphoma that involves the CNS. The goal of this research study is to see if adding rituximab to the stem cell mobilization and conditioning regimens helps treat lymphoma that involves the central nervous system.


Description:

If the screening procedures confirm that you are eligible to participate in the research study you will have the following procedures. Stem cell mobilization - this will take place over at least 9 days to prepare you to donate your stem cells for your autologous transplant. The drugs cytarabine, rituximab and Neupogen (G-CSF) will be given. You will be in the hospital for 2 days to receive the cytarabine infusions (and the 1st rituximab infusion of day 1 of stem cell mobilization). Then you will be discharged. You will receive the Neupogen injections as an outpatient. Stem cell collection (leukapheresis) - When your doctor determines that your stem cell count is high enough you will have your stem cells collected by a procedure called leukapheresis. Leukapheresis is performed by collecting blood from a vein and processing it through a machine that removes the stem cells that are needed to produce bone marrow. The rest of the blood is returned to you through another vein. The harvested stem cells will be frozen and stored. These cells will be returned to you after you complete the conditioning regimen with high dose chemotherapy. Conditioning regimen (high dose chemotherapy) - You will enter the hospital for the conditioning regimen and stay for about 30 days after you receive your stem cell transplant. The conditioning regimen to help kill cancer cells before your stem cell transplant will take place over 9 days. All drugs will be given intravenous (through an IV). Infusion of stem cells (stem cell transplant) - Your cells will be given to you through your vein, similar to an IV infusion. The infusion usually takes several hours. After you are discharged, you will be asked to return at about 4 weeks, 8 weeks, 12 weeks and 14 weeks after the stem cell transplant. At each visit you will have a physical exam, questions to measure your mental functioning, blood tests. About 14 weeks after the stem cell transplant you will have an eye exam, echocardiogram, lung function tests, whole body PET-CT scan, brain MRI or CT scan, MRI or CT of spinal cord (for patients who may have lymphoma in the spinal cord), collection of cerebral spinal fluid, and bone marrow aspiration. You will have follow-up visits for 6 month to up to 4 years after the stem cell transplant.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - One of the following clinical criteria:secondary CNS NHL; synchronous CNS NHL; relapsed PCNSL; relapsed IOL; PCNSL or IOL which has only achieved a PR after adequate initial therapy - Must have CNS or intraocular involvement by NHL - Subjects with secondary CNS NHL, relapsed PCNSL, or relapsed IOL will have received Salvage therapy for their CNS disease - Subjects with synchronous CNS NHL will have received primary therapy including CNS-directed therapy - Must demonstrate a partial or complete response of the CNS and systemic disease to pre-enrollment therapy, and must be in PR or CR at the time of enrollment - Age >/= 18 and </= 75 years - Life expectancy >/= 3 months - ECOG performance status </= 2 - Must have adequate organ function as defined by the protocol Exclusion Criteria: - Stable or progressive CNS or systemic disease (SD orPD) at the time of enrollment - Systemic or intrathecal chemotherapy or radiotherapy within 2 weeks prior to starting therapy on study - Actively receiving any other study agents aimed to treat their disease - A prior HDT-ASCT or allogeneic stem cell transplant (myeloablative or nonmyeloablative) - Burkitt's lymphoma or acute lymphoblastic lymphoma - A history of severe allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, thiotepa, busulfan, cyclophosphamide, or rituximab - Serious uncontrolled concurrent illness - Any evidence of prior exposure to Hepatitis B virus - HIV-positive - Pregnant or lactating - A history of malignancy other than NHL or PCNSL unless disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin

Study Design


Intervention

Procedure:
Autologous stem cell transplant
Autologous stem cell transplant following high-dose chemotherapy
Drug:
High-dose chemotherapy
High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide

Locations

Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Massachusetts General Hospital Dana-Farber Cancer Institute, Genentech, Inc., Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chen YB, Batchelor T, Li S, Hochberg E, Brezina M, Jones S, Del Rio C, Curtis M, Ballen KK, Barnes J, Chi AS, Dietrich J, Driscoll J, Gertsner ER, Hochberg F, LaCasce AS, McAfee SL, Spitzer TR, Nayak L, Armand P. Phase 2 trial of high-dose rituximab with — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Patients With CNS Involvement by B-cell NHL, Relapsed PCNSL, or Relapsed PIOL Who Are Alive and Progression-free at One Year The proportion of patients with central nervous system (CNS) involvement by B-cell Non-Hodgkin's Lymphoma (NHL), relapsed primary central nervous system lymphoma (PCNSL), or relapsed primary intraocular lymphoma (PIOL) who are alive and progression-free at one year. Relapse was defined as per standard PCNSL criteria from clinical and MRI criteria. 3 years
Secondary 2-year Progression Free Survival (PFS) The percentage of participants alive and without disease progression at 2 years. Disease progression was judged through clinical impression and MRI imaging. 2 years
Secondary 2-year Overall Survival (OS) The percentage of participants alive after two years 2 years
Secondary Response Rate The number of participants that achieved complete remission following high dose chemotherapy and autologous stem cell transplantation (ASCT). Complete remission is defined as the disappearance of all evidence of disease. Response was judged by MRI assessment. 3 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT01878890 - Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure. Phase 1
Completed NCT04152148 - A Phase I Clinical Trial of BAT4306F on Safety, Tolerability and Pharmacokinetics for Patients Phase 1
Recruiting NCT05096234 - 18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma Phase 2
Recruiting NCT05191225 - Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study Phase 4
Recruiting NCT05623982 - Phase Ib/II Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Phase 1/Phase 2
Active, not recruiting NCT03664635 - MB-CART20.1 Lymphoma Phase 1/Phase 2
Recruiting NCT02356159 - Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation Phase 1/Phase 2
Terminated NCT01699581 - Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant Phase 2
Completed NCT01763398 - Analysis of the Risk Factors for the Neutropenic Fever in the High Risk NHL Patients for Developing Febrile Neutropenia Who Received 3-weekly CHOP-like Chemotherapy With Primary G-CSF Prophylaxis; Prospective Multicenter Observation Study N/A
Completed NCT01205503 - Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release Phase 2
Completed NCT00975975 - Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer Phase 2
Completed NCT00969462 - Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma Phase 4
Completed NCT00659425 - CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma Phase 1
Withdrawn NCT00577161 - Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL Phase 3
Completed NCT00608907 - An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib) Phase 1
Completed NCT00533728 - Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma Phase 1
Terminated NCT00475332 - Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar Phase 2
Completed NCT00581646 - Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance N/A
Completed NCT00430352 - MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma. Phase 4