Rituximab, Bendamustine and Melphalan Chemo-immunotherapy Followed by Reinfusion of One's Own Stem Cell for Treatment of B-cell Lymphoma in Elderly Patients
|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.|
|ClinicalTrials.gov Identifier: NCT03352765|
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : August 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: rituximab Drug: bendamustine Drug: melphalan Procedure: Autologous Stem Cell Transplantation (ASCT)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a phase I/II single arm, open label trial|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 20, 2017|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
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 -11 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. The conditioning timeline can be modified if there are patient scheduling conflicts.
rituximab 375 mg/m2 on days -11 and -4, The second dose of rituximab (day -4) is administered 7 days after the first dose (day -11), +/- 1 day. Rituximab may be administered by a local oncologist. If the participant has a CD20 negative tumor, rituximab can be omitted from the conditioning regimen.
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.
Procedure: Autologous Stem Cell Transplantation (ASCT)
reinfusion of autologous stem cells on day 0.
- 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
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
|Contact: Parastoo Dahi, MDfirstname.lastname@example.org|
|Contact: Paul Hamlin, MD||908-542-3366|
|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|
|Principal Investigator:||Parastoo Dahi, MD||Memorial Sloan Kettering Cancer Center|