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Non-Myeloablative Conditioning and Unrelated Umbilical Cord Blood Transplantation for Children and Adults With Serious Oncohematologic Diseases


N/A
N/A
75 Years
Open (Enrolling)
Both
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

Non-Myeloablative Conditioning and Unrelated Umbilical Cord Blood Transplantation for Children and Adults With Serious Oncohematologic Diseases


OBJECTIVES:

- Determine the frequency, extent, and rate of donor (myeloid and lymphoid) engraftment
in patients with serious hematologic malignancies treated with nonmyeloablative
conditioning regimen comprising fludarabine, cyclophosphamide, and low-dose total-body
irradiation followed by unrelated allogeneic umbilical cord blood transplantation and
post-transplant immunosuppression comprising cyclosporine and mycophenolate mofetil.

- Correlate clinical and umbilical cord blood-related factors with engraftment in
patients treated with this regimen.

- Determine transplant-related complications, in terms of toxicity, myelosuppression,
infections, and acute and chronic graft-versus-host disease, in patients treated with
this regimen.

- Determine disease-free and overall survival of patients treated with this regimen.

- Determine treatment-related mortality of patients treated with this regimen.

OUTLINE: This is a uncontrolled, pilot study.

- Nonmyeloablative conditioning regimen: Patients receive fludarabine IV over 30 minutes
daily on days -6 to -2 and cyclophosphamide IV over 2 hours on day -6 and undergo
low-dose total-body irradiation (TBI) on day 0.

- Unrelated allogeneic umbilical cord blood transplantation (UCBT): After completion of
TBI, patients undergo 1 or 2 unrelated allogeneic UCBTs on day 0.

- Post-transplant immunosuppression: Patients receive oral or IV cyclosporine daily
beginning on day -3 and continuing until day 180 and oral or IV mycophenolate mofetil
twice daily on days 0-30.

Patients are followed periodically for 1 year after transplantation.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following hematologic malignancies:

- Acute myeloid leukemia (AML) with or without history of myelodysplastic
syndromes, meeting 1 of the following criteria:

- In first complete remission (CR-1) with unfavorable cytogenetics and/or
achieved CR-1 after ≥ 1 course of induction therapy

- Secondary or treatment-related AML

- In second or further complete remission

- Relapsed with ≤ 20% blasts in the bone marrow AND no circulating blasts

- Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:

- In CR-1 with unfavorable cytogenetics or elevated WBC at presentation OR
failed to achieve CR-1 after ≥ 4 weeks of induction therapy

- In second or further complete remission

- Relapsed with ≤ 20% blasts in the bone marrow AND no circulating blasts

- Other acute leukemic variants allowed at the discretion of the principal
investigator

- Chronic myelogenous leukemia (CML), meeting 1 of the following criteria:

- In first chronic phase AND refractory to or unable to tolerate imatinib
mesylate

- In second or further chronic phase

- In first or second accelerated phase

- Myelodysplastic syndromes with intermediate 2- or high-risk International
Prognosis Scoring System (IPSS) score, including any of the following:

- Refractory anemia

- Refractory anemia with excess blasts

- Chronic myelomonocytic leukemia

- Myeloproliferative disorders with poor prognosis, including any of the
following:

- Myelofibrosis with myeloid metaplasia

- No ≥ grade 3 myelofibrosis

- Atypical CML

- Juvenile myelomonocytic leukemia

- Other clonal hemopathies with an accepted poor prognosis

- Multiple myeloma with chromosome 13 abnormalities and/or progression after prior
autologous bone marrow transplantation (BMT)

- Chronic lymphocytic leukemia, meeting 1 of the following criteria:

- Primary refractory OR relapsed and refractory disease (less than partial
remission)

- Relapsed twice on or after prior chemotherapy

- Lymphoma, meeting both of the following criteria:

- Hodgkin's or non-Hodgkin's lymphoma in > CR-1 OR failed primary induction

- Chemosensitive disease, defined as > 50% reduction in mass size after the
most recent chemotherapy

- Must meet ≥ 1 of the following criteria:

- Over 45 years of age

- Has undergone prior autologous or allogeneic BMT

- Charlson^ comorbidity score ≥ 2

- Must have a high degree of tumor control (salvage therapy allowed)

- At high risk for treatment-related mortality with a myeloablative conditioning
regimen

- No massive splenomegaly

- Patients may become eligible after splenectomy or radiotherapy to the spleen

- No 5/6 or 6/6 HLA-matched related donor available

- No well-matched (i.e., ≥ 9/10 HLA match by high-resolution typing) unrelated donor
available

PATIENT CHARACTERISTICS:

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

Hepatic

- Bilirubin ≤ 2 times upper limit of normal (ULN)

- Transaminases ≤ 4 times ULN (unless due to underlying disease)

Renal

- Creatinine clearance ≥ 50 mL/min

Cardiovascular

- Ejection fraction ≥ 30%

Pulmonary

- DCLO ≥ 35%

Other

- Negative pregnancy test

- No uncontrolled viral, bacterial, or fungal infection

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- See Disease Characteristics

Radiotherapy

- See Disease Characteristics

Other

- At least 3 months since prior immunosuppressive therapy

- At least 10 days since prior salvage therapy for patients not in at least morphologic
or radiologic complete remission

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Gordon L. Phillips, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

Unspecified

Study ID:

CDR0000448637

NCT ID:

NCT00255684

Start Date:

December 2003

Completion Date:

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • graft versus host disease
  • adult acute myeloid leukemia in remission
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • recurrent adult acute myeloid leukemia
  • childhood acute myeloid leukemia in remission
  • recurrent childhood acute myeloid leukemia
  • adult acute lymphoblastic leukemia in remission
  • recurrent adult acute lymphoblastic leukemia
  • childhood acute lymphoblastic leukemia in remission
  • recurrent childhood acute lymphoblastic leukemia
  • acute undifferentiated leukemia
  • accelerated phase chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • childhood chronic myelogenous leukemia
  • refractory anemia with excess blasts
  • refractory anemia
  • chronic myelomonocytic leukemia
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • juvenile myelomonocytic leukemia
  • primary myelofibrosis
  • refractory hairy cell leukemia
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory multiple myeloma
  • refractory chronic lymphocytic leukemia
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV 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 inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • de novo myelodysplastic syndromes
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent childhood large cell lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent mantle cell lymphoma
  • relapsing chronic myelogenous leukemia
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • previously treated myelodysplastic syndromes
  • recurrent adult Hodgkin lymphoma
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • childhood myelodysplastic syndromes
  • Neoplasms
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Lymphoma, Large-Cell, Immunoblastic
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642