Eligibility Criteria

Autologous Hematopoietic Stem Cell Transplantation

1. Age < 70 years
2. Cardiac Function: ejection fraction > 45%
3. Liver Function: Bilirubin < 2.0 mg/dl and transaminases < 2x normal,
4. Renal Function : creatinine clearance > 50 ml/min
5. Pulmonary Function: DLCO > 60% predicted
6. Serologies: Patients cannot be HIV + or have active Hepatitis B , Hepatitis C or HTLV-1
7. Karnofsky performance status >: 80%
8. No significant co-morbid medical or psychiatric illness which would significantly compromise the patient's clinical care and chances of survival.

Allogeneic Hematopoietic Stem Cell/Bone Marrow Transplantation

Eligibility criteria for an allogeneic transplantation are the same as listed above (in general), with the following requirements:

1. Age < 50 years
2. Availability of an HLA-matched sibling donor (six of six or five of six HLA-match).
3. Normal LFT's (unless related to disease).
4. Cardiac function: ejection fraction > 45%.

Non-myeloablative Allogeneic Hematopoietic Stem Cell/ Bone Marrow Transplantation

Eligibility criteria for an allogeneic transplantation are the same as listed (unless otherwise specified in protocol) for the allogeneic candidate with the following exceptions:

1. Age < 65 years
2. A potential patient may have a co-morbid medical condition that precludes them from receiving a full allogeneic bone marrow transplantation.

Disease Specific Eligibility Criteria (Autologous)

1. Acute Myelogenous Leukemia
2. Acute Lymphocytic Leukemia
• Allogeneic
1. 1st remission: high risk only. For example:
• Prior myelodysplasia (secondary AML)
• All chromosomal findings (including normal) except Inversion 16, t(8:21), t(15:17)
• 2 or more inductions required to achieve a CR
2. Early 1st relapse defined as 5% - 30% blasts or recurrent positive cytogenetics.
3. 2nd response/CR (after 1st relapse)
4. First relapse within 3 months of induction.
• Autologous
  1. 1st remission: high risk only. For example
  • Prior myelodysplasia (secondary AML)
  • All chromosomal findings (including normal) except Inversion 16, t(8:21), t(15:17)
  2. Ineligible for allogeneic transplant because of age or lack of donor
  3. Early 1st relapse defined as 5% - 30% blasts or recurrent positive cytogenetics
  4. 2 or more inductions required to achieve a CR
  5. 2nd response/CR after 1st relapse
3. Chronic Myelogenous Leukemia
• Allogeneic
1. 1st or subsequent chronic phase
2. accelerated phase
• Autologous
1. For older patients without a donor (related or unrelated) who obtain a cytogenetic response from interferon and/or chemotherapy, consider autologous stem cell transplantation.
4. Chronic Lymphocytic Leukemia/Low grade NHL
• Allogeneic
1. Full allo if age
2. < 50 in first PR/CR as standard of care -on research protocol only.
3. Mini-allo if >50 < 65, or in second remission (PR or CR) with HLA sibling donor.
• Autologous
1. < Second remission (PR or CR) with minimal bone marrow disease (< 20%).
5. Multiple Myeloma
• Allogeneic
1. Consider for younger patients with an HLA sibling donor match, with one or more of the following criteria:
• Young age
• Chromosome 13 abnormality
• Relapsed/refractory
• Autologous
1. Failure/progression following 1st or 2nd standard dose regimen
2. First remission (PR or CR) for high-risk patients (Durie-Salmon Stage 2-3, chromosome 13 abnormality).
6. Myelodysplasia
• Allogeneic (preferred)
1. Severe cytopenias, i.e. <500 ANC or <30K platelets of any age or
2. Increased marrow blasts >5%
3. CMML
• Allogeneic (preferred)
1. No allo donor available with increased marrow blasts <5% or CMML in CR1 CMML
7. Anemia
• Allogeneic
1. For HLA-sib in patients <50 years
2. "Severe" disease, i.e. bone marrow with <25% cellularity (or <50% cellularity with <30% hematopoietic cells) without increased blasts and normal chromosomes and at least two of the following:
• 500 ANC
• <:20,000 platelets
• anemia with corrected reticulocyte <1%
• Autologous
1. This option is not available for this disease. Please see Allogeneic.
8. Hodgkin's Disease
• Allogeneic (preferred)
1. At the time of diagnosis in high-risk patients (CALGB Phase III Trial)
2. Failure to achieve 1st complete remission (PR or primary refractory disease)
3. 1st relapse or later
• Autologous
  1. Consider in young patients with very aggressive disease and an HLA-sib match (i.e. Primary refractory disease, relapsed refractory disease)
9. Non-Hodgkin's Lymphoma/Intermediate or High-Grade (incl. WHO follicular grade III)
   • Allogeneic
   1. Consider in young patients with very aggressive disease and an HLA-sib match (i.e. Primary refractory disease, relapsed refractory disease)
   2. Marrow involvement >20%
   • Autologous (Preferred)
   1. At the time of diagnosis in high-risk patients (Pt with High-intermediate (2 risks) or High (3 risks) based on IPI Index - CALGB Phase III Trial)
   2. Failure to achieve 1st complete remission (PR or stable disease) Prior to or at the time of ³ CR2 or PR2
10. Non-Hodgkin's Lymphoma/WHO follicular Grade I and II
11. Breast Cancer
• Allogeneic
1. This option is not available for this disease. Please see Autologous.
• Autologous
  1. Stage II-IIIa
  • > 4 axillary nodes involved with metastatic carcinoma
  2. Stage IIIb inflammatory carcinoma
  3. Stage IV disease -patients demonstrating chemotherapy sensitive disease in CR or with minimal amount of disease.
12. Germ Cell Cancer
• Allogeneic
1. This option is not available for this disease. Please see Autologous.
• Autologous
1. Primary refractory disease
2. At first relapse or later
13. Acute Lymphocytic Leukemia
• Allogeneic (preferred)
1. 1st remission: high risk only. For example:
• Adverse chromosome changes. For example, t(9;22), t(4;11), t(8;14), t(2;8), t(8;22)
2. Early 1st relapse defined as 5% - 30% blasts
3. 1st relapse or second remission
4. Primary refractory
• Autologous
1. Ineligible for allogeneic transplant or lack of donor with one of the following features:
1. High-risk disease as defined in ASH Education book, 1999, p. 91
2. 1st relapse or 2nd remission
3. Early 1st relapse defined as 5% - 30% blasts or recurrent +cytogenetics
4. Primary refractory