We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rituximab, Bendamustine and Melphalan Chemo-immunotherapy Followed by Reinfusion of One's Own Stem Cell for Treatment of B-cell Lymphoma in Elderly Patients

This study is currently recruiting participants.
Verified November 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03352765
First Posted: November 24, 2017
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose
This study is testing a combination of chemo-immuno therapy called RBM. RBM consists of combination of drugs: rituximab, bendamustine, and melphalan followed by reinfusion of the participants own stem cells which is called autologous stem cell transplant (ASCT). Compared to the standard BEAM regimen, this RBM regimen may or may not be less effective in lymphoma, but will likely have fewer side effects.

Condition Intervention Phase
Lymphoma Drug: rituximab Drug: bendamustine Drug: melphalan Procedure: Autologous Stem Cell Transplantation (ASCT) Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
This is a phase I/II single arm, open label trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Rituximab, Bendamustine and Melphalan Conditioning and Autologous Stem Cell Transplantation for Treatment of Relapsed/ Refractory Diffuse Large B-cell Lymphoma (Rel/Ref DLBCL) or Transformed Lymphoma in Elderly Patients

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • Dose limiting toxicities (DLT) [ Time Frame: 1 year ]
    are defined as grade > 3, non-hematologic toxicity related to treatment excluding grade 3 nausea or vomiting responsive to anti-emetic treatment, grade 3 diarrhea responding to anti-diarrheal treatment, grade 3 fatigue, grade 3 skin rash responsive to topical or systemic steroids, grade 3 fevers (> 40 degrees Celsius for < 24 hours) and alopecia per CTCAE


Estimated Enrollment: 32
Actual Study Start Date: November 20, 2017
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rituximab, bendamustine & melphalan and ASCT
This is a phase I/II study of rituximab, bendamustine and melphalan (RBM) conditioning followed by ASCT in elderly patients with B-cell NHL. Conditioning regimen consist of rituximab 375 mg/m2 on days -10 and -4, bendamustine 160 mg/m2 intravenously on days -3 and -2; melphalan 140 mg/m2 intravenously on day -1 before the reinfusion of autologous stem cells on day 0.
Drug: rituximab
rituximab 375 mg/m2 on days -10 and -4,
Drug: bendamustine
bendamustine 160 mg/m2 intravenously on days -3 and -2
Drug: melphalan
melphalan 140 mg/m2 intravenously on day -1 before the reinfusion of autologous stem cells on day 0.
Procedure: Autologous Stem Cell Transplantation (ASCT)
reinfusion of autologous stem cells on day 0.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Phase I eligibility:

  • Any - B-cell non-Hodgkin lymphoma would be eligible for phase I portion of the study.

Phase II eligibility:

  • Histologically confirmed diagnosis of rel/ref DLBCL, or diffuse large B cell lymphoma transformed from an indolent lymphoma Since the endpoint of the Phase I portion is safety, any B-cell NHL can be enrolled. However, the PFS endpoint varies greatly amongst different types of lymphoma. In order to accurately interpret the survival data, a homogeneous cohort of patients with DLBCL will be evaluated. DLBCL is the most aggressive B-NHL with limited options. Other B-NHL's are generally more indolent and have more options available to them.

Additional eligibility for both the phase I and phase II studies:

  • Age ≥ 70 at the time of enrollment
  • Hematopoietic Stem Cell Transplant Comorbidity Index (HCT-CI) ≥ 3^50
  • KPS ≥ 70
  • Males must agree to use an acceptable form of contraception per institutional practices.
  • Complete or partial response to salvage chemotherapy by IWG Working Group Criteria
  • Cardiac ejection fraction of ≥ 45%
  • Hemoglobin-adjusted diffusing capacity of carbon monoxide (DLCO) of ≥45%
  • Creatinine clearance of ≥50 mL/min
  • Completion of most recent salvage therapy within 8 weeks of enrollment
  • Direct bilirubin ≤2.0 mg/dL in the absence of suspected Gilbert's disease (if Gilbert's disease is suspected, the total bilirubin must be ≤3.0 mg/dL), and AST ≤ 2.5 ULN.

Exclusion Criteria:

  • Disease progression by IWG Working Group Criteria since last therapy
  • Patients with history of CNS involvement
  • Prior autologous or allogeneic stem cell transplantation
  • Patients who have failed bendamustine-based regimen previously
  • Patients within 6 months of MI and stroke will be excluded
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352765


Contacts
Contact: Parastoo Dahi, MD 212-639-5846 dahip@mskcc.org
Contact: Paul Hamlin, MD 908-542-3366

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Parastoo Dahi, MD    212-639-5846      
Contact: Paul Hamlin, MD    908-542-3366      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Parastoo Dahi, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03352765     History of Changes
Other Study ID Numbers: 17-373
First Submitted: November 21, 2017
First Posted: November 24, 2017
Last Update Posted: November 24, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Rituximab
Bendamustine
Melphalan
Autologous Stem Cell Transplantation (ASCT)
17-373

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Melphalan
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents