Clinical trial · Interventional
Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
A Phase II Study Of Intensive Induction Chemotherapy Followed By Autologous Stem Cell Transplantation Plus Immunotherapy 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and rituximab with peripheral stem cell transplantation in treating patients who have 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 (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemo/immuno/autolog transplant
- description
- Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma
- interventionNames
- Biological: filgrastim
- Biological: rituximab
- Drug: carmustine
- Drug: cyclophosphamide
- Drug: cytarabine
- Drug: doxorubicin hydrochloride
- Drug: etoposide
- Drug: leucovorin calcium
- Drug: methotrexate
- Drug: prednisone
- Drug: vincristine sulfate
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 2 years
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed mantle cell lymphoma
* Presenting with at least one of the following:
* Coexpression of CD20 (or CD19) and CD5 and a lack of CD23 expression by immunophenotyping
* Positive for cyclin D1 by immunostaining
* Presence of t(11,14) by cytogenetic analysis
* Molecular evidence of bcl-1/IgH rearrangement
* Stage I-IV disease
* Stage III or IV if nodular histology mantle cell lymphoma present
* Any stage for other mantle cell histologies
* No mantle zone histology
* No active CNS disease
* No symptomatic meningeal lymphoma
* No known CNS parenchymal lymphoma
* Lumbar puncture showing mantle cell lymphoma allowed
* Bidimensionally measurable disease greater than 1 cm
* Nonmeasurable disease includes the following:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Abdominal masses not confirmed and followed by imaging techniques
* Cystic lesions
* Lesions in a previously irradiated area
PATIENT CHARACTERISTICS:
Age:
* 18 to 69
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Hepatitis B surface antigen and hepatitis C antibody positive patients must meet all of the following criteria:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST no greater than 3 times ULN
* Liver biopsy shows no greater than grade 2 fibrosis and no cirrhosis
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* LVEF at least 45% by MUGA or echocardiogram
Other:
* No known hypersensitivity to murine products
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No more than 1 prior dose of rituximab
Chemotherapy:
* No more than 1 prior cycle of chemotherapy
* At least 3 weeks since prior chemotherapy
* No other concurrent chemotherapeutic agents
Endocrine therapy:
* No chronic use of oral corticosteroids for ongoing medical condition
* No concurrent hormonal therapy except for non-lymphoma-related conditions (e.g., insulin for diabetes)
* Other concurrent corticosteroids for adrenal failure, diffuse alveolar hemorrhage, carmustine pneumonitis, or as an anti-emetic allowed
Radiotherapy:
* No prior radiotherapy for mantle cell lymphoma
* Concurrent palliative radiotherapy allowed
* Concurrent cranial radiotherapy for asymptomatic meningeal lymphoma allowed
Surgery:
* At least 2 weeks since prior major surgeryReferences
Publications (4)
- RESULTDamon LE, Johnson JL, Niedzwiecki D, Cheson BD, Hurd DD, Bartlett NL, Lacasce AS, Blum KA, Byrd JC, Kelly M, Stock W, Linker CA, Canellos GP. Immunochemotherapy and autologous stem-cell transplantation for untreated patients with mantle-cell lymphoma: CALGB 59909. J Clin Oncol. 2009 Dec 20;27(36):6101-8. doi: 10.1200/JCO.2009.22.2554. Epub 2009 Nov 16. PMID 19917845
- RESULTHsi ED, Jung SH, Lai R, Johnson JL, Cook JR, Jones D, Devos S, Cheson BD, Damon LE, Said J. Ki67 and PIM1 expression predict outcome in mantle cell lymphoma treated with high dose therapy, stem cell transplantation and rituximab: a Cancer and Leukemia Group B 59909 correlative science study. Leuk Lymphoma. 2008 Nov;49(11):2081-90. doi: 10.1080/10428190802419640. PMID 19021050
- RESULTDamon LE, Johnson J, Niedzwiecki D, et al.: Immuno-chemotherapy (IC) and autologous stem cell transplant (ASCT) for untreated patients (pts) with mantle cell lymphoma (MCL): CALGB 59909. [Abstract] Blood 108 (11): A-2737, 2006.
- DERIVEDLiu H, Johnson JL, Koval G, Malnassy G, Sher D, Damon LE, Hsi ED, Bucci DM, Linker CA, Cheson BD, Stock W. Detection of minimal residual disease following induction immunochemotherapy predicts progression free survival in mantle cell lymphoma: final results of CALGB 59909. Haematologica. 2012 Apr;97(4):579-85. doi: 10.3324/haematol.2011.050203. Epub 2011 Nov 18. PMID 22102709