Study on How Stem Cell Dose Affects Recovery After High-Dose Therapy and Stem Cell Transplant for Difficult-to-Treat Large B-cell Lymphoma
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT02570542
This study is exploring how the amount of stem cells given during a transplant affects recovery in patients with relapsed or hard-to-treat Diffuse Large B-cell Lymphoma (DLBCL).
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to understand how different doses of stem cells impact recovery after a stem cell transplant in patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL).
Description
After joining the study, patients will receive a treatment to increase their stem cells, guided by their doctor, using a medication called plerixafor. The goal is to collect more than 6 million stem cells per kilogram of body weight. If this number isn't reached, patients won't be part of the random selection process but will still be monitored for disease progression and survival. Those who have enough stem cells collected will be admitted to the hospital for a planned stem cell transplant. Patients will be randomly assigned to receive either a lower dose (3-4 million stem cells per kilogram) or a higher dose (6-8 million stem cells per kilogram) during the transplant. The exact dose may vary slightly due to how the cells are stored. Patients will receive standard care after the transplant, including support to help blood cell growth, antibiotics to prevent infections, and transfusions if needed, following hospital guidelines.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Diagnosed with relapsed or hard-to-treat Diffuse Large B-cell Lymphoma (DLBCL) or follicular lymphoma that has changed to DLBCL after one previous chemotherapy treatment.
- Have a performance status score of 70 or higher, meaning able to care for oneself but unable to carry out work activities.
- Show a complete or partial response to one line of salvage chemotherapy without needing radiation before the transplant.
- Eligible for high-dose therapy and stem cell transplant.
- Kidney function must be adequate, with specific creatinine levels or clearance rates.
- Last cycle of recent salvage therapy must be within 8 weeks of joining the study.
- Total bilirubin must be less than 2.0 mg/dL, with exceptions for suspected Gilbert's disease.
- Women of childbearing age and men must agree to use effective contraception.
Exclusion Criteria
- Disease has progressed since the last therapy.
- Have had a previous stem cell transplant.
- Have an HIV infection.
- Have other health conditions that would prevent stem cell mobilization or high-dose therapy, as determined by the doctor.
- Plan to have maintenance therapy after the transplant.
- Have had salvage therapy that includes radiation to specific areas.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Nebraska Medical Center | 68198-7680 | Omaha | Nebraska |
| Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only) | Basking Ridge | New Jersey | |
| Memorial Sloan Kettering Monmouth (Consent and Follow up Only) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Consent and Follow Up Only) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Commack (Consent and Follow-up Only) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester | 10604 | Harrison | New York |
| Northwell Health (Data collection only) | 11030 | Manhasset | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Columbia University | New York | New York | |
| University of Rochester Medical Center | 14642 | Rochester | New York |
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