Norris Cotton Cancer Center

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