Clinical trial · Interventional
Combination Chemotherapy, Bone Marrow or Peripheral Stem Cell Transplantation, and/or Biological Therapy in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
Phase II Study of Multimodality Therapy in 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation and/or biological therapy in treating patients who have stage III, stage IV, or recurrent mantle cell lymphoma.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (15)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage III, IV, or recurrent mantle cell lymphoma * CD5 positive OR * Evidence of bcl-1 oncogene overexpression * Measurable or evaluable disease with at least one of the following: * Clear cut radiographic findings * Clearly defined bidimensional defect or mass at least 2 cm in diameter on radionuclide or CT scan * Enlarged spleen extending at least 2 cm below costal margin with lymphomatous involvement only * Enlarged liver with proof of lymphoma by biopsy * CNS involvement allowed * Fully HLA matched donor for allogeneic transplantation PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-3 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 3.0 mg/dL Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No significant cardiac disease Other: * No other prior malignancies except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No other medical problems that would preclude study * HIV negative * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics * Prior chemotherapy, including doxorubicin, allowed Endocrine therapy: * See Disease Characteristics * Prior steroids allowed Radiotherapy: * See Disease Characteristics * Prior radiotherapy allowed excluding the indicator lesions Surgery: * Not specified
References
Publications (1)
- RESULTEvens AM, Winter JN, Hou N, Nelson BP, Rademaker A, Patton D, Singhal S, Frankfurt O, Tallman MS, Rosen ST, Mehta J, Gordon LI. A phase II clinical trial of intensive chemotherapy followed by consolidative stem cell transplant: long-term follow-up in newly diagnosed mantle cell lymphoma. Br J Haematol. 2008 Feb;140(4):385-93. doi: 10.1111/j.1365-2141.2007.06908.x. Epub 2007 Dec 19. PMID 18162124