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Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Primary Purpose

Leukemia, Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carmustine
cisplatin
cyclophosphamide
dexamethasone
etoposide
melphalan
paclitaxel
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Waldenstrom macroglobulinemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed low grade follicular lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia with no greater than 12 months of prior standard therapy Follicular lymphoma Must have poor prognosis disease defined as any of the following: Any nodal or extranodal tumor mass with a diameter more than 7 cm Involvement of at least 3 nodal sites, each of which has a diameter greater than 3 cm Systemic symptoms Substantial splenic involvement no greater than 5 cm below left costal margin Serous effusions (ascites, pleural or pericardial effusions) Orbital or epidural involvement Ureteral compression Leukemia presentation (at least 500/microliter) Increased LDH level Greater than 20% bone marrow involvement Mantle cell lymphoma No mantle zone morphology Chronic lymphocytic leukemia Must have either anemia (hemoglobin less than 10 g/dL), thrombocytopenia (less than 100,000/mm3), cytogenetic abnormalities including +12 and 11q, elevated LDH levels, labeling index at least 2%, systemic symptoms, or hepatosplenomegaly No active CNS disease 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. PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: At least 4,000/g CD34+ peripheral blood stem cells available See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal No active chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: FEV1, FVC, and DLCO at least 50% of predicted Other: HIV negative No active infection requiring intravenous antibiotics Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Prior corticosteroids allowed Radiotherapy: At least 4 weeks since prior local radiotherapy Surgery: Not specified

Sites / Locations

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
October 15, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
University of Maryland Greenebaum Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00003402
Brief Title
Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Official Title
Autologous Transplantation With and High Dose BCNU and Melphalan Followed by Consolidation With DCEP Plus Taxol/Cisplatin in Patients With Poor Prognosis Low Grade Non-Hodgkin's Lymphoma and Chronic Lymphocyte Leukemia, Who Have Received < or = 12 Months of Standard Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Maryland, Baltimore
Collaborators
University of Maryland Greenebaum Cancer Center

4. Oversight

5. Study Description

Brief Summary
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 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 peripheral stem cell transplantation plus combination chemotherapy in treating patients who have low-grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Detailed Description
OBJECTIVES: I. Evaluate the complete and partial response rates to treatment with peripheral blood stem cell supported high dose carmustine and melphalan followed by consolidation therapy with dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) and dexamethasone, paclitaxel, and cisplatin in patients with poor prognosis low grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia and no greater than 12 months of prior standard therapy. II. Evaluate the incidence of early deaths (less than 60 days posttransplant) in comparison with historical experience in this patient population. III. Evaluate the toxicity of posttransplantation chemotherapy with DCEP and dexamethasone, paclitaxel, and cisplatin in these patients. OUTLINE: Patients receive carmustine IV over 2 hours on day -2 and melphalan IV on day -1 followed by peripheral blood stem cell infusion on day 0. At 3 months and 9 months after completion of autologous transplantation, patients receive cyclophosphamide, etoposide, and cisplatin by continuous IV infusion for 4 days plus dexamethasone orally every day for 4 days. At 6 and 12 months after completion of autologous transplantation, patients receive dexamethasone orally every day for 4 days, paclitaxel continuous IV infusion over 6 hours on day 2, and cisplatin continuous IV infusion over 24 hours on day 3. PROJECTED ACCRUAL: There will be 12-35 patients accrued into this study over 1-2.5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
Waldenstrom macroglobulinemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Procedure
Intervention Name(s)
bone marrow ablation with stem cell support
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed low grade follicular lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia with no greater than 12 months of prior standard therapy Follicular lymphoma Must have poor prognosis disease defined as any of the following: Any nodal or extranodal tumor mass with a diameter more than 7 cm Involvement of at least 3 nodal sites, each of which has a diameter greater than 3 cm Systemic symptoms Substantial splenic involvement no greater than 5 cm below left costal margin Serous effusions (ascites, pleural or pericardial effusions) Orbital or epidural involvement Ureteral compression Leukemia presentation (at least 500/microliter) Increased LDH level Greater than 20% bone marrow involvement Mantle cell lymphoma No mantle zone morphology Chronic lymphocytic leukemia Must have either anemia (hemoglobin less than 10 g/dL), thrombocytopenia (less than 100,000/mm3), cytogenetic abnormalities including +12 and 11q, elevated LDH levels, labeling index at least 2%, systemic symptoms, or hepatosplenomegaly No active CNS disease 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. PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: At least 4,000/g CD34+ peripheral blood stem cells available See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal No active chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: FEV1, FVC, and DLCO at least 50% of predicted Other: HIV negative No active infection requiring intravenous antibiotics Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Prior corticosteroids allowed Radiotherapy: At least 4 weeks since prior local radiotherapy Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry R. Meisenberg, MD
Organizational Affiliation
University of Maryland Greenebaum Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

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