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LeukemiaPhase 2NCT00002718

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

A Phase 2 study testing anti-thymocyte globulin, filgrastim and cyclophosphamide in people with Leukemia and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. Read more about this study

Who is it for?
Ages Up to 49 years
Conditions the study is for
Leukemia, Lymphoma, Myelodysplastic Syndromes
What is being tested?
anti-thymocyte globulin, filgrastim and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
Nov 1995to Oct 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 49 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official 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

RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of T-cell depleted bone marrow and G-CSF stimulated peripheral stem cell transplantation in treating patients with leukemia, lymphoblastic lymphoma, myelodysplastic syndrome, or aplastic anemia.

Read the detailed description

OBJECTIVES:

  • Determine the potential of T-cell-depleted bone marrow and peripheral blood stem cells (PBSC) from HLA-haplotype, partially matched related donors to induce extended disease-free survival in patients with leukemia, lymphoblastic lymphoma, myelodysplastic syndrome, or severe aplastic anemia who would otherwise be ineligible for transplantation because of the lack of an HLA-identical related or unrelated donor.
  • Determine the impact of filgrastim (G-CSF)-stimulated, CD34+, E-rosette and T-cell-depleted PBSC derived from an HLA-haplotype, partially matched donor on the incidence and quality of engraftment, kinetics, and quality of hematopoietic and immunologic reconstitution, and incidence and severity of graft-versus-host disease (GVHD) in these patients.
  • Correlate the doses of PBSC and clonable T-cells with the incidence of engraftment, extent of chimerism, incidence and severity of acute and chronic GVHD, characteristics of hematopoietic and immunologic reconstitution, and overall and disease-free survival rates at 2-4 years after transplantation in these patients.

OUTLINE: Patients are stratified by number of HLA-incompatible alleles (1 vs 2 or 3).

  • Harvest: Beginning 6-10 days before transplantation, allogeneic bone marrow is harvested and treated in vitro. Beginning 5-6 days before transplantation, filgrastim (G-CSF)-stimulated, allogeneic peripheral blood stem cells (PBSC) are harvested, selected for CD34+ cells, and treated in vitro. If feasible, autologous bone marrow is harvested in the event of allogeneic graft failure.
  • Myeloablation: Patients undergo total body irradiation 3 times a day on days -9 to -6, thiotepa IV over 4 hours on days -5 and -4, and cyclophosphamide IV on days -3 and -2.
  • Transplantation: CD34+, E-rosette and T-cell-depleted PBSC are infused over 15 minutes and then T-cell-depleted bone marrow is infused over 1-5 minutes on day 0. Patients receive G-CSF IV over 30 minutes beginning on day 1 and continuing until blood counts recover and then tapering. Patients receive anti-thymocyte globulin IV over 4-6 hours on days 8, 10, 12, and 14 and oral methylprednisolone on days 8-14 followed by tapered doses on days 15-17.
  • CNS prophylaxis: Beginning at least 2 months after transplantation, patients with acute lymphocytic leukemia (ALL) and no history of CNS leukemia receive cytarabine intrathecally (IT) monthly for 6 months and patients with ALL and a history of CNS leukemia receive cytarabine IT monthly for 12 months.

Patients with graft failure are offered autologous bone marrow transplantation (BMT) or second allogeneic BMT.

Patients are followed at 1, 3, 6, and 12 months and then annually for 3 years.

Being tested
anti-thymocyte globulin, filgrastim, cyclophosphamide, cytarabine, methylprednisolone
Keywords
recurrent childhood acute lymphoblastic leukemia, stage IV childhood lymphoblastic lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, accelerated 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, stage IV adult lymphoblastic lymphoma, recurrent adult lymphoblastic lymphoma, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, juvenile myelomonocytic leukemia
Medical subject headings
Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myeloid, Accelerated Phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00002718
Study groupRoleWhat they receive
Candidates for transplantExperimentalPts stratified by number of HLA-incompatible alleles(1 vs 2 or 3). Harvest:Begin 6-10 d before transplant,allogeneic BM is harvest \& tx in vitro. Begin 5-6 d before transplant,G-CSF-stimulated,PBSC harvest,selected for CD34+ cells,\& treatment in vitro. If doable,ABM harvest in event of allogeneic graft failure. Myeloablation:Pts u/g TBI 3x d days -9 to -6, thiotepa IV over 4hrs days -5 \& -4, \& cyclophosphamide IV days -3 \& -2. Transplant:CD34+, E-rosette \& T-cell-depleted PBSC infuse over 15mins \& T-cell-depleted bone marrow infused over 1-5mins day 0. Pts get G-CSF IV over 30 min begin day 1 \& continue til blood counts recover \& tapering. Pts get anti-thymocyte globulin IV over 4-6hrs days 8,10,12,\&14 \& oral methylprednisolone days 8-14 followed by tapered doses days 15-17. See detailed description for more details.
Receives: Biological: anti-thymocyte globulin; Biological: filgrastim; Drug: cyclophosphamide; Drug: cytarabine; Drug: methylprednisolone; Drug: thiotepa; Procedure: in vitro-treated bone marrow transplantation; Procedure: in vitro-treated peripheral blood stem cell transplantation; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall disease survival

    Measured: 2 to 4 years post transplant

Secondary outcomes (1)

  1. To correlate progenitor cell doses and doses of clonable T-cells

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 1995
  3. Primary completionJan 2004
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002718
Sponsor's protocol ID
95-084
Other IDs
P30CA008748, MSKCC-95084, NCI-V96-0809
Status last verified
Dec 2015
First submitted
1 Nov 1999
Last updated
23 Dec 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-thymocyte globulin, filgrastim and cyclophosphamide in people with Leukemia and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall disease survival (time frame: 2 to 4 years post transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002718.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2015.

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