High-Dose Therapy and Autologous Stem Cell Transplant for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+15 other locations

Sergio A. Giralt, MD - MSK Bone Marrow ...

Overseen byCraig Sauter, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing how different amounts of a specific type of stem cell affect the outcomes of patients who receive their own stem cells back after treatment. It targets patients undergoing stem cell transplants. The treatment involves collecting, freezing, and re-infusing different amounts of these stem cells to see which dose works best. This method has been used in various clinical trials for treating multiple diseases, including multiple sclerosis and multiple myeloma.

Eligibility Criteria

Adults over 18 with relapsed or refractory DLBCL who've had one prior anthracycline-based chemotherapy can join. They should be fairly fit (KPS ≥ 70), have decent kidney function, and not too high bilirubin levels in the blood. Women and men must use birth control, and they shouldn't have HIV or other conditions that would interfere with stem cell procedures.

Inclusion Criteria

My total bilirubin is over 2.0 mg/dL, but my direct bilirubin is under 2.0 mg/dL.

I am eligible for a treatment involving high-dose therapy and my own stem cells.

I've had a good response to one round of chemotherapy without prior high-dose therapy or stem cell transplant.

+7 more

Exclusion Criteria

My doctor thinks my health conditions won't allow for a specific stem cell treatment.

I have received targeted radiation therapy as part of my salvage treatment.

I am HIV positive.

+3 more

Participant Groups

The trial is examining how different doses of CD34+ stem cells affect recovery after a high-dose therapy followed by an autologous stem cell transplant in patients with certain types of B-cell lymphoma.

2Treatment groups

Experimental Treatment

Active Control

Group I: 6-8 x10^6 CD34+ stem cells/kgExperimental Treatment4 Interventions

Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guideline practices.

Group II: 3-4 x 10^6 CD34+ stem cells/kgActive Control4 Interventions