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Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer

Primary Purpose

Chronic Myeloproliferative Disorders, Leukemia, Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anti-thymocyte globulin
busulfan
carboplatin
cyclophosphamide
etoposide
fludarabine phosphate
melphalan
thiotepa
total-body irradiation
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloproliferative Disorders focused on measuring recurrent childhood acute lymphoblastic leukemia, recurrent cutaneous T-cell non-Hodgkin lymphoma, Burkitt lymphoma, Waldenstrom macroglobulinemia, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, polycythemia vera, essential thrombocythemia, refractory anemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, T-cell large granular lymphocyte leukemia, acute undifferentiated leukemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent adult T-cell leukemia/lymphoma, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, prolymphocytic leukemia, intraocular lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, recurrent mantle cell lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, recurrent mycosis fungoides/Sezary syndrome, primary myelofibrosis, childhood chronic myelogenous leukemia, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12), childhood myelodysplastic syndromes, aplastic anemia, unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Diagnosis of one of the following: Severe aplastic anemia as defined by either of the following: Marrow cellularity (< 25% [or 25-50% cellularity with < 30% of remaining cells hematopoietic in origin]) At least 2 of the following abnormal peripheral blood counts: Reticulocyte count < 1% (corrected for hematocrit) Platelet count < 20,000/mm^3 Neutrophil count < 500/mm^3 Histologically confirmed hematologic malignancy, including any of the following: Acute leukemia Resistant or recurrent disease after combination chemotherapy with at least one standard regimen OR in first remission and at high risk of relapse Acute myeloid leukemia (AML) (antecedent myelodysplastic syndromes [MDS], secondary AML, or high-risk cytogenetic abnormalities) Acute lymphoblastic leukemia (ALL) (high-risk cytogenetic abnormalities) Chronic myeloid leukemia (CML) Chronic phase, accelerated phase, or blast phase Myeloproliferative disorders or MDS, including any of the following: Myelofibrosis Polycythemia vera* Essential thrombocythemia* Refractory anemia Refractory anemia with excess blasts Refractory anemia with excess blasts in transformation Chronic myelomonocytic leukemia NOTE: * Only if transformed to AML or MDS Lymphoproliferative disease Recurrent or persistent, symptomatic disease after first-line chemotherapy, including any of the following: Chronic lymphocytic leukemia (CLL) (≥ 20% marrow involvement) Waldenstrom macroglobulinemia Low-grade non-Hodgkin lymphoma Intermediate or high-grade non-Hodgkin lymphoma, meeting 1 of the following criteria: Resistant or recurrent disease after combination chemotherapy with one standard regimen Lymphoblastic lymphoma or small noncleaved cell lymphoma in first remission and at high risk of relapse CNS disease Bone marrow disease and LDH greater than 300 Solid tumor that would otherwise be treated on RPCI-DS-9115 (or equivalent autologous stem transplant protocol) AND has a syngeneic donor Autologous bone marrow transplant not possible (or desirable) due to 1 of the following: History of marrow tumor Inadequate marrow dose Abnormal marrow histology or function prior to storage Thrombocytopenia or leukopenia Marrow cellularity < 20% Histocompatible donor identified Well-matched donor, as defined by 1 of the following: Family member matched for 5 or 6 HLA specificities (A, B, DR)* Unrelated donor meeting compatibility criteria of the National Marrow Donor Program (matched for HLA A, B, and DRB1 antigens)* Identical twin sibling If a compatible cord blood donor is identified and there is no suitable unrelated donor available, patient may receive cord blood transplant NOTE: *Patients ≤ 25 years of age may be singly mismatched at the A or B loci 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. PATIENT CHARACTERISTICS: Age: 4 to 70 Performance status: Zubrod 0-2 OR Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin < 3 times normal (unless due to disease) Alkaline phosphatase < 3 times normal (unless due to disease) SGOT < 3 times normal (unless due to disease) Hepatitis B surface antigen negative No severe hepatic disease that would preclude study participation Renal: Creatinine normal Creatinine clearance ≥ 50 mL/min No severe renal disease that would preclude study participation Cardiovascular: Cardiac ventricular ejection fraction ≥ 50% by MUGA or echocardiogram No uncontrolled or severe cardiovascular disease (e.g., myocardial infarction, congestive heart failure, symptomatic angina, life threatening arrhythmia, or hypertension within the past 6 months) Pulmonary: DLCO or DLVA ≥ 50% predicted (corrected for hemoglobin or alveolar ventilation) Other: No serious concurrent medical or psychiatric illness No other serious organ dysfunction (unless due to underlying disease), including the following: Uncontrolled bacterial, viral, or fungal infection Uncontrolled peptic ulcer disease Uncontrolled diabetes mellitus HIV negative Cytomegalovirus status known Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Pretransplant cytoreductive chemotherapy allowed for patients with relapsed or refractory disease Endocrine therapy: Not specified Radiotherapy: Not eligible for total-body irradiation if prior radiotherapy exceeded the following limits: Mediastinum: 3,600 cGy Heart: 3,600 cGy Whole lungs: 1,200 cGy Small bowel: 3,600 cGy Kidneys: 1,200 cGy Whole liver: 1,600 cGy Cranial spinal: 3,600 cGy Brain: 4,000 cGy Retina: 4,000 cGy Surgery: Not specified

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Regimen 1

Regimen 2

Regimen 3

Regimen 4

Regimen 5

Regimen 6

Regimen 7

Regimen 8

Regimen 9

Arm Description

Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.

Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3.

Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1.

Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2.

Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1.

Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4.

Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2.

Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1.

Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.

Outcomes

Primary Outcome Measures

CR Rate
Rate of Complete Remission by Day +100

Secondary Outcome Measures

Toxicity/TRM at Day 100
Death due to treatment related causes before day +100 after BMT
4 Year PFS
progression free survival estimate at 4 years post BMT (events are disease progression/relapse and death due to any cause)
4 yr OS
Overall survival estimate at 4 years post BMT

Full Information

First Posted
November 1, 1999
Last Updated
July 19, 2021
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00003816
Brief Title
Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer
Official Title
Allogeneic Blood or Marrow Transplantation for Hematologic Malignancy and Aplastic Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 19, 1998 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor stem cell helps stop the growth of cancer or abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known which combination chemotherapy regimen is most effective when given before a donor stem cell transplant in treating aplastic anemia or hematologic cancer. PURPOSE: This phase II/III trial is studying different combination chemotherapy regimens to compare how well they work when given before donor stem cell transplant in treating patients with aplastic anemia or hematologic cancer.
Detailed Description
OBJECTIVES: Compare the morbidity, mortality, and overall outcome of patients with severe aplastic anemia or hematologic malignancy treated with standard vs novel conditioning regimens followed by allogeneic stem cell transplantation. Examine the influence of donor histocompatibility on outcome by comparing matched/related, mismatched/related (with or without T-cell depletion), and matched/unrelated transplants with stratification for type of preparative regimen. Ensure that patients with uncommon diagnoses will be treated in a uniform fashion with the best therapy available. OUTLINE: Patients are stratified according to risk of relapse (standard-risk: acute leukemia in first complete remission, chronic myelogenous leukemia in first chronic phase, lymphoma in sensitive first relapse or second remission, primary or untreated myelodysplastic syndromes, or untreated severe aplastic anemia vs high-risk: all others). Patients are assigned to one of the following conditioning regimens based on diagnosis, risk of relapse, and donor relatedness: Regimen 1: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Regimen 2: Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3. Regimen 3: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1. Regimen 4: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2. Regimen 5: Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1. Regimen 6: Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. Regimen 7: Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2. Regimen 8: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1. Regimen 9: Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. All patients then receive donor stem cell infusions on day 0. Some patients may undergo involved-field radiotherapy 4-8 weeks after transplant. Patients will be taken off study after a minimum of 4 years of follow up. PROJECTED ACCRUAL: At least 405 patients will be accrued for this study within 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Nonmalignant Neoplasm, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
Keywords
recurrent childhood acute lymphoblastic leukemia, recurrent cutaneous T-cell non-Hodgkin lymphoma, Burkitt lymphoma, Waldenstrom macroglobulinemia, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, polycythemia vera, essential thrombocythemia, refractory anemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, T-cell large granular lymphocyte leukemia, acute undifferentiated leukemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent adult T-cell leukemia/lymphoma, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, prolymphocytic leukemia, intraocular lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, recurrent mantle cell lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, recurrent mycosis fungoides/Sezary syndrome, primary myelofibrosis, childhood chronic myelogenous leukemia, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12), childhood myelodysplastic syndromes, aplastic anemia, unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
361 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen 1
Arm Type
Experimental
Arm Description
Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
Arm Title
Regimen 2
Arm Type
Experimental
Arm Description
Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3.
Arm Title
Regimen 3
Arm Type
Experimental
Arm Description
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1.
Arm Title
Regimen 4
Arm Type
Experimental
Arm Description
Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2.
Arm Title
Regimen 5
Arm Type
Experimental
Arm Description
Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1.
Arm Title
Regimen 6
Arm Type
Experimental
Arm Description
Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4.
Arm Title
Regimen 7
Arm Type
Experimental
Arm Description
Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2.
Arm Title
Regimen 8
Arm Type
Experimental
Arm Description
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1.
Arm Title
Regimen 9
Arm Type
Experimental
Arm Description
Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
Intervention Type
Biological
Intervention Name(s)
anti-thymocyte globulin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
thiotepa
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
total-body irradiation
Intervention Description
Given twice daily for 3 days
Primary Outcome Measure Information:
Title
CR Rate
Description
Rate of Complete Remission by Day +100
Time Frame
day 100
Secondary Outcome Measure Information:
Title
Toxicity/TRM at Day 100
Description
Death due to treatment related causes before day +100 after BMT
Time Frame
Day +100
Title
4 Year PFS
Description
progression free survival estimate at 4 years post BMT (events are disease progression/relapse and death due to any cause)
Time Frame
4 years
Title
4 yr OS
Description
Overall survival estimate at 4 years post BMT
Time Frame
4-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of one of the following: Severe aplastic anemia as defined by either of the following: Marrow cellularity (< 25% [or 25-50% cellularity with < 30% of remaining cells hematopoietic in origin]) At least 2 of the following abnormal peripheral blood counts: Reticulocyte count < 1% (corrected for hematocrit) Platelet count < 20,000/mm^3 Neutrophil count < 500/mm^3 Histologically confirmed hematologic malignancy, including any of the following: Acute leukemia Resistant or recurrent disease after combination chemotherapy with at least one standard regimen OR in first remission and at high risk of relapse Acute myeloid leukemia (AML) (antecedent myelodysplastic syndromes [MDS], secondary AML, or high-risk cytogenetic abnormalities) Acute lymphoblastic leukemia (ALL) (high-risk cytogenetic abnormalities) Chronic myeloid leukemia (CML) Chronic phase, accelerated phase, or blast phase Myeloproliferative disorders or MDS, including any of the following: Myelofibrosis Polycythemia vera* Essential thrombocythemia* Refractory anemia Refractory anemia with excess blasts Refractory anemia with excess blasts in transformation Chronic myelomonocytic leukemia NOTE: * Only if transformed to AML or MDS Lymphoproliferative disease Recurrent or persistent, symptomatic disease after first-line chemotherapy, including any of the following: Chronic lymphocytic leukemia (CLL) (≥ 20% marrow involvement) Waldenstrom macroglobulinemia Low-grade non-Hodgkin lymphoma Intermediate or high-grade non-Hodgkin lymphoma, meeting 1 of the following criteria: Resistant or recurrent disease after combination chemotherapy with one standard regimen Lymphoblastic lymphoma or small noncleaved cell lymphoma in first remission and at high risk of relapse CNS disease Bone marrow disease and LDH greater than 300 Solid tumor that would otherwise be treated on RPCI-DS-9115 (or equivalent autologous stem transplant protocol) AND has a syngeneic donor Autologous bone marrow transplant not possible (or desirable) due to 1 of the following: History of marrow tumor Inadequate marrow dose Abnormal marrow histology or function prior to storage Thrombocytopenia or leukopenia Marrow cellularity < 20% Histocompatible donor identified Well-matched donor, as defined by 1 of the following: Family member matched for 5 or 6 HLA specificities (A, B, DR)* Unrelated donor meeting compatibility criteria of the National Marrow Donor Program (matched for HLA A, B, and DRB1 antigens)* Identical twin sibling If a compatible cord blood donor is identified and there is no suitable unrelated donor available, patient may receive cord blood transplant NOTE: *Patients ≤ 25 years of age may be singly mismatched at the A or B loci 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. PATIENT CHARACTERISTICS: Age: 4 to 70 Performance status: Zubrod 0-2 OR Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin < 3 times normal (unless due to disease) Alkaline phosphatase < 3 times normal (unless due to disease) SGOT < 3 times normal (unless due to disease) Hepatitis B surface antigen negative No severe hepatic disease that would preclude study participation Renal: Creatinine normal Creatinine clearance ≥ 50 mL/min No severe renal disease that would preclude study participation Cardiovascular: Cardiac ventricular ejection fraction ≥ 50% by MUGA or echocardiogram No uncontrolled or severe cardiovascular disease (e.g., myocardial infarction, congestive heart failure, symptomatic angina, life threatening arrhythmia, or hypertension within the past 6 months) Pulmonary: DLCO or DLVA ≥ 50% predicted (corrected for hemoglobin or alveolar ventilation) Other: No serious concurrent medical or psychiatric illness No other serious organ dysfunction (unless due to underlying disease), including the following: Uncontrolled bacterial, viral, or fungal infection Uncontrolled peptic ulcer disease Uncontrolled diabetes mellitus HIV negative Cytomegalovirus status known Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Pretransplant cytoreductive chemotherapy allowed for patients with relapsed or refractory disease Endocrine therapy: Not specified Radiotherapy: Not eligible for total-body irradiation if prior radiotherapy exceeded the following limits: Mediastinum: 3,600 cGy Heart: 3,600 cGy Whole lungs: 1,200 cGy Small bowel: 3,600 cGy Kidneys: 1,200 cGy Whole liver: 1,600 cGy Cranial spinal: 3,600 cGy Brain: 4,000 cGy Retina: 4,000 cGy Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip L. McCarthy, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer

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