Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy and Radiation Therapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory T-cell Lymphoma, Hodgkin's Lymphoma, or Non-Hodgkin's Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed Over 15 to physiologic age 60 NCI NU-95H4T NCI-G00-1692, NCT00004907

Objectives

1. Determine the toxicity of an intensive program of chemoradiotherapy followed by HLA identical related bone marrow or peripheral blood stem cell transplantation in patients with relapsed or refractory cutaneous T-cell lymphoma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma.
2. Determine the response rate and disease free survival in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically proven relapsed or refractory cutaneous T-cell lymphoma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma of the following types:
  • Diffuse small lymphocytic/marginal zone
  • Grade I follicular small cleaved cell
  • Grade II follicular mixed cell
  • Diffuse small cleaved cell
  • Grade III follicular large cell
  • Diffuse mixed cell
  • Diffuse large cell
  • Immunoblastic large cell



• HLA identical related donor available
  • Phenotypically HLA identical, MLC nonstimulatory donor eligible if no HLA identical related donor is available



• Relapse following autologous bone marrow transplantation allowed if an HLA identical related donor is available



• Eligible for total body irradiation



• No active uncontrolled CNS disease

 [Note: A new classification scheme for adult non-Hodgkin's 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.]

Prior/Concurrent Therapy:

• See Disease Characteristics

Patient Characteristics:

Age:

• Over 15 to physiologic age 60

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No congestive heart failure
• No myocardial infarction within the past 3 months
• No significant arrhythmia requiring medication
• Resting LVEF normal

Pulmonary:

• No significant nonneoplastic pulmonary disease (e.g., chronic obstructive pulmonary disease) that would preclude therapy with cytotoxic drugs
• DLCO at least 50% of predicted* OR
• FEV1 and/or FVC at least 50% of predicted*

 [Note: * Unless due to lymphoma, including Hodgkin's lymphoma]

Other:

• Not pregnant
• Negative pregnancy test
• No active serious medical condition that would preclude aggressive cytotoxic chemotherapy
• HIV negative and no clinical evidence of AIDS

Expected Enrollment

Not specified

Outline

HLA identical related donors undergo harvest of bone marrow or peripheral blood stem cells (PBSC).

Patients are assigned to one of two treatment groups based on prior radiation to abdomen or mediastinum:

• Group A (prior radiation no greater than 2,000 cGy): Patients with complete response (CR) or partial response (PR) after completion of chemotherapy receive cyclophosphamide IV over 1 hour on days -6 and -5, followed by total body irradiation twice daily on days -4 to -1. Patients with minimal response after completion of chemotherapy receive cyclophosphamide IV over 1 hour on days -8 and -7, followed by etoposide IV over 30 hours beginning on day -6, followed by total body irradiation twice daily on days -4 to -1.



• Group B (prior radiation greater than 2,000 cGy): Patients with CR or PR after completion of chemotherapy receive oral busulfan every 6 hours on days -7 to -4, followed by cyclophosphamide IV over 1 hour on days -3 and -2. Patients with minimal response after completion of chemotherapy receive oral busulfan every 6 hours on days -9 to -6, followed by cyclophosphamide IV over 1 hour on days -5 and -4, followed by etoposide IV over 30 hours beginning on day -3.



• Both groups: Bone marrow or PBSC are reinfused on day 0. Patients with bulky nodal disease (greater than 5 cm) may undergo involved field radiotherapy two weeks before transplantation.

Patients are followed every month for 1 year.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Leo Gordon, MD, Protocol chair		Ph: 312-695-4546 Email: l-gordon@northwestern.edu

Registry Information
Official Title		High-Dose Chemoradiotherapy with Stem Cell Allogeneic Cellular Rescue in Patients with Relapsed or Refractory Hematologic Malignancy - A Phase I/II Study
Trial Start Date		1999-10-28
Registered in ClinicalTrials.gov		NCT00004907
Date Submitted to PDQ		2000-01-13
Information Last Verified		2004-11-08
NCI Grant/Contract Number		P30-CA60553

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