Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01746173
Other study ID # 12-388
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date July 2013
Est. completion date October 2014

Study information

Verified date January 2023
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The current standard of care for the frontline treatment of peripheral T-cell lymphomas (PTCL) is induction chemotherapy followed by autologous stem cell transplantation (ASCT). However, many patients are unable to get to ASCT or relapse after ASCT, with a poor prognosis. Recently, a novel ASCT conditioning regimen of gemcitabine, busulfan and melphalan (Gem/Bu/Mel) has been reported to lead to favorable outcomes in this disease. We therefore designed a frontline regimen of CHOEP induction followed by Gem/Bu/Mel ASCT, and report the results of a phase 2 study of this regimen in patients with PTCL.


Description:

Objectives: Primary - To estimate the proportion of patients alive and progression-free at 24 months after beginning induction therapy Secondary - To estimate the response rate (complete remission (CR) and partial remission (PR)) after CHOEP x 6 and after Gem/Bu/Mel ASCT - To estimate overall survival (OS), progression-free survival (PFS), cumulative incidence of relapse (CIR), and non-relapse mortality (NRM) - To estimate the toxicity (grade 3 and above) - To estimate the rate of successful stem cell mobilization after CHOEP in responding patients - To estimate the proportion of patients who can successfully complete the entire treatment regimen - To estimate the time to engraftment of neutrophil and platelet engraftment after ASCT - To determine whether tumor DNA can be detected in peripheral blood of patients before therapy - To evaluate the changes and prognostic relevance in detectable tumor DNA in peripheral blood after induction chemotherapy (CHOEP) and after Gem/Bu/Mel ASCT


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Diagnosis of T-Cell lymphoma with mandatory pathologic review at Brigham and Women's Hospital or Massachusetts General Hospital - Measurable disease - Candidate for Autologous Stem Cell Transplant Exclusion Criteria: - Prior anti-lymphoma chemotherapy (except steroids/radiotherapy for urgent palliation, one prior cycle of CHOP or up to 2 prior cycles of CHOEP) - Pregnant or breastfeeding - Alk-positive ACL - Significant neuropathy precluding vincristine administration - Known hypersensitivity to any of the agents used in the treatment - Uncontrolled intercurrent illness - Receiving other investigational agents - History of a different malignancy except if disease free for at least 5 years or have cervical cancer in situ or basal cell/squamous cell carcinoma of the skin - HIV positive on anti-retroviral therapy

Study Design


Intervention

Drug:
Cyclophosphamide

Doxorubicin

Vincristine

Etoposide

Prednisone

Filgrastim

Plerixafor

Procedure:
Stem Cell Collection

Drug:
Palifermin

Gemcitabine

Busulfan

Melphalan

Procedure:
Stem Cell Transplant


Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 24-month Progression-Free Survival Rate 24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.
Secondary Induction Response Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy. Response was assessed was using a combination of CT scans and PET scans. Partial and complete response were categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks. Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).
See also
  Status Clinical Trial Phase
Completed NCT00992446 - Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma Phase 2
Active, not recruiting NCT04774068 - Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas Phase 1
Completed NCT03263637 - Study to Assess Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AZD4573 in Relapsed/Refractory Haematological Malignancies Phase 1
Recruiting NCT05377827 - Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies Phase 1
Completed NCT01919619 - Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies Phase 2
Completed NCT03061188 - Phase I/Ib Study of Nivolumab & Veliparib in Patients With Advanced Solid Tumors & Lymphoma Phase 1
Completed NCT03833180 - A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001) Phase 1
Terminated NCT03195010 - Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia Phase 2
Completed NCT00723099 - Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer Phase 2
Completed NCT02424968 - CD8+ Memory T-Cells as Consolidative Therapy After Donor Non-myeloablative Hematopoietic Cell Transplant in Treating Patients With Leukemia or Lymphoma Phase 2
Recruiting NCT05127135 - Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies Phase 1
Completed NCT00880815 - Fludarabine, Bendamustine, and Rituximab in Treating Participants With Lymphoid Cancers Undergoing Stem Cell Transplant Phase 1
Active, not recruiting NCT03333486 - Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer Phase 2
Recruiting NCT02859402 - Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas Phase 2
Recruiting NCT04594135 - Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies Phase 1
Recruiting NCT04934774 - Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances Phase 1