Clinical trial · Interventional
Intensive Induction Therapy Followed by High Dose Chemo and BM Transplant for Mantle Cell Lymphoma
Intensive Induction Therapy Followed by Early High Dose Chemotherapy and Bone Marrow Transplantation for Mantle Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with mantle cell lymphoma have a grave prognosis. They usually have an initial response to therapy, however progress early in the course of the disease and have very poor survival. We hypothesize that the emergence of drug resistance is responsible for this early failure of therapy and therefore intensive therapy at induction followed by high dose therapy immediately may produce a better outcome.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensive Induction-BMT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intensive Induction-BMT
- description
- Patients will undergo induction regimen and stem cell mobilization with cyclophosphamide for bone marrow transplant (BMT). This will be immediately followed by high dose therapy with stem cell support.
- interventionNames
- Procedure: Intensive Induction-BMT
Primary outcomes (2)
- measure
- Disease Free Survival (DFS)
- timeFrame
- 1 year
- description
- Number of patients who did not have documented recurrence for at 1 year after bone marrow transplantation. We would like to detect an improvement over 0.25 in DFS at one year. Thirty (30) patients will be accrued and complete the transplant phase of therapy. We anticipate only 50% of patients enrolling to complete transplant, noting that approximately 60 patients total will need to be accrued. With 30 patients we can detect an improvement as small as 17% in magnitude, i.e., from an assumed 1-year DFS of 25% to a 1-year DFS of 42% with approximately 80% power. This is based on a one-sided test of hypothesis, testing at significance level 0.05 and the assumption that the true underlying 1-year DFS is 0.25. Greater differences in DFS are expected. If the 1-year DFS with the new treatment is greater than 42% the power is increased.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have biopsy proven mantle cell lymphoma confirming mantle cell lymphoma. (Flow cytometry, and cyclin D1 or t (11;14) tests of disease site should be done if available at some time in the patient's course before this therapy) * Radiologic staging studies may be performed up to 6 weeks prior to starting therapy and not be repeated if the treating physician feels it unnecessary * No other prior malignancy is permitted except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for one year. * Age \> or = to 18 years of age * For patients who are in first remission from a prior regimen, at least 3 weeks must elapse from a prior chemotherapy and at least 1 week from radiation or antibody therapy. Exclusion Criteria: * Significant medical and/or psychiatric illness which, in the opinion of the investigators, may compromise any aspect of the planned treatment. * The patient cannot have been exposed to chemotherapy to treat any of these diseases (other than mantle cell lymphoma) for at least 3 years prior to entry on this protocol.
References
Publications (0)
Data not yet available