T-cell Depleted Bone Marrow and G-CSF Stimulated Peripheral Stem Cell Transplantation From Related Donors in Treating Patients With Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, or Aplastic Anemia

• Register: ClinicalTrials.gov
• Last refreshed on: 4 January 2016
• Main ID: NCT00002718
• Date of registration: 01/11/1999
• Prospective Registration: No
• Primary sponsor: Memorial Sloan Kettering Cancer Center
• Public title: T-cell Depleted Bone Marrow and G-CSF Stimulated Peripheral Stem Cell Transplantation From Related Donors in Treating Patients With Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, or Aplastic Anemia
• Scientific title: A Phase II Trial of T-Cell Depleted Marrow Grafts Combined With Infusions of G-CSF Stimulated, CD34 Ceprate Stem Cell Column Selected, E-Rosette Depleted Peripheral Blood Progenitor Cells Derived From HLA Haplotype Matched Related Donors for Patients With Leukemia Lacking an HLA-Matched Related or Unrelated Donor
• Date of first enrolment: November 1995
• Target sample size: 31
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00002718
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Richard J. O'Reilly, MD
• Affiliation: Memorial Sloan Kettering Cancer Center

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- One of the following diagnoses:

- Acute myelogenous leukemia (AML) meeting 1 of the following conditions:

- Failed to achieve first remission after an intensive induction regimen
containing an anthracycline and cytarabine

- In second remission and not enrolled in a protocol for autologous bone
marrow transplantation

- Failed to achieve or sustain second remission

- In first remission but at high risk of relapse because of 1 of the
following factors:

- High-risk cytogenetic features (monosomy 7,5q-, trisomy 8, or t(9;22))

- AML secondary to treatment of a prior malignancy and without good-risk
cytogenetic features of t(8;21), t(15;17), or inv 16

- AML secondary to myelodysplastic disease

- Acute lymphocytic leukemia (ALL) meeting 1 of the following conditions:

- In second remission with initial relapse occurring within 2 years of
diagnosis

- In first complete remission with high-risk cytogenetics (t(9;22) or
t(4;11))

- In third or subsequent remission

- Failed to achieve or sustain a second remission

- Chronic myelogenous leukemia (CML) in first or second chronic phase or
accelerated phase

- Stage IV lymphoblastic lymphoma not in first remission or that failed to achieve
a remission within the first 4 weeks of induction therapy

- Juvenile CML

- Myelodysplastic syndrome

- Severe aplastic anemia unresponsive to anti-thymocyte globulin or cyclosporine

- No CNS or skin involvement with leukemia

- No requirement for mediastinal irradiation

- No healthy, HLA-identical related donor of at least 1 year of age or matched
unrelated donor available within 4-6 months

- Availability of a healthy, 1-3 HLA-A, -B, and -DR mismatched related donor

- Willing and able to undergo general anesthesia for marrow donation and a 5-day
course of filgrastim (G-CSF) with 2 daily leukaphereses

PATIENT CHARACTERISTICS:

Age:

- Under 50 (50 and over allowed on a case-by-case basis)

Performance status:

- Age 16 and over:

- Karnofsky 70-100%

- Under age 16:

- Lansky 50-100%

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin less than 2.0 mg/dL (in the absence of liver involvement)

- AST less than twice normal (in the absence of liver involvement)

Renal:

- Creatinine normal OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- Asymptomatic or LVEF greater than 50% at rest, with improvement during exercise

Pulmonary:

- Asymptomatic or DLCO greater than 50% predicted (corrected for hemoglobin)

Other:

- No known hypersensitivity to mouse protein or chicken egg products

- No active viral, bacterial, or fungal infection

- HIV-1, HIV-2, HTLV-1, and HTLV-2 negative

- No other concurrent medical condition that would preclude transplantation

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics



Age minimum: N/A
Age maximum: 49 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Leukemia

Myelodysplastic Syndromes

Lymphoma

Myelodysplastic/Myeloproliferative Neoplasms

Intervention(s)

Drug: methylprednisolone

Procedure: in vitro-treated bone marrow transplantation

Biological: anti-thymocyte globulin

Radiation: radiation therapy

Drug: cyclophosphamide

Procedure: in vitro-treated peripheral blood stem cell transplantation

Biological: filgrastim

Drug: thiotepa

Drug: cytarabine

Primary Outcome(s)

overall disease survival [Time Frame: 2 to 4 years post transplant]

Secondary Outcome(s)

To correlate progenitor cell doses and doses of clonable T-cells [Time Frame: 2 years]

Secondary ID(s)

95-084

P30CA008748

MSKCC-95084

NCI-V96-0809

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)