Clinical trial · Interventional
Combination Chemotherapy With or Without Total-Body Irradiation Followed By Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
High-Dose Therapy and Autologous Stem Cell Transplantation During Remission in Poor-Risk Age-Adjusted International Prognostic Index High and High-Intermediate Risk Group Patients With Intermediate Grade and High-Grade Non-Hodgkin's Lymphoma Including 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: Giving chemotherapy and radiation therapy to the entire body before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The patient's stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with or without total-body irradiation followed by a stem cell transplant and to see how well it works in treating patients with non-Hodgkin 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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| total-body irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Irradiation in conditioning
- description
- total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor (G-CSF), autologous hematologic stem cell transplantation, peripheral blood stem cell transplantation
- interventionNames
- Drug: cyclophosphamide
- Drug: etoposide
- Procedure: autologous hematopoietic stem cell transplantation
- Procedure: peripheral blood stem cell transplantation
- Radiation: total-body irradiation
- Drug: G-CSF
- type
- ACTIVE_COMPARATOR
- label
- Carmustine in conditioning
- description
- Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor (G-CSF), autologous hematopoietic stem cell transplantation, peripheral blood stem cell transplantation
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: * DISEASE CHARACTERISTICS: * Biopsy-proven diagnosis of high-grade (small noncleaved cell lymphoma \[SNCCL\] or immunoblastic lymphoma) or intermediate-grade non-Hodgkin lymphoma (NHL) including mantle cell lymphoma (MCL) * SNCCL patients with all of the following factors at presentation of disease: * Lactate dehydrogenase (LDH) \> 500 IU/L * Unresectable bulky mass \> 10 cm * Stage IV disease with bone marrow involvement * MCL Patients with stage IV disease or in International Prognostic Index (IPI) high- or high-intermediate-risk group at the time of diagnosis * Considered at diagnosis to be high- (3 risk factors) or high-intermediate-risk (2 risk factors) based on an age-adjusted IPI * Poor prognostic factors at diagnosis include stage III or IV disease, lactate dehydrogenase (LDH) level above normal, or ECOG performance status (PS) 2-4 * Patients with primary mediastinal large cell lymphoma with or without sclerosis who at diagnosis had elevated LDH level with bulky mediastinal mass \> 10 cm associated with a pleural effusion on chest radiography or computer tomography, or who have persistent mediastinal mass with positive disease by post-treatment gallium GA 67 scan * Must have attained a complete response or partial response to first-line standard conventional chemotherapy * ECOG PS 0-1 OR Karnofsky PS 80-100% * Serum creatinine \< 1.5 mg/dL OR creatinine clearance \> 60 mL/min * FEV\_1 \> 65% of predicted measurement or DLCO ≥ 45% of predicted measurement * Cardiac ejection fraction \> 50% by echocardiogram * Bilirubin ≤ 1.5 x normal * SGOT or SGPT ≤ 2 x normal Exclusion Criteria: * Evidence of lymphoma or \< 10% lymphomatous involvement of bone by bilateral bone marrow aspiration and biopsy * Abnormal cytogenetic study of bone marrow aspirate sample NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. * Positive HIV antibody * Prior malignancies except for adequately treated basal cell or squamous cell carcinoma of the skin * Hepatitis B surface antigen positivity * Prior bone marrow transplantation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior bone marrow transplantation
References
Publications (1)
- BACKGROUNDNademanee A, Molina A, Dagis A, Snyder DS, O'Donnell MR, Parker P, Stein A, Smith E, Planas I, Kashyap A, Spielberger R, Fung H, Krishnan A, Bhatia R, Wong KK, Somlo G, Margolin K, Chow W, Sniecinski I, Vora N, Slovak M, Niland JC, Forman SJ. Autologous stem-cell transplantation for poor-risk and relapsed intermediate- and high-grade non-Hodgkin's lymphoma. Clin Lymphoma. 2000 Jun;1(1):46-54. doi: 10.3816/clm.2000.n.004. PMID 11707813