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



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:70 - Any
Updated:8/15/2018
Start Date:November 20, 2017
End Date:November 2020
Contact:Parastoo Dahi, MD
Email:dahip@mskcc.org
Phone:212-639-5846

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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

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.


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

- 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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 212-639-5846
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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