Total Marrow and Lymphoid Irradiation and Chemotherapy for Myelodysplastic Syndrome or Acute Leukemia

Last updated: January 16, 2018
Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Myelodysplastic Syndromes (Mds)

White Cell Disorders

Treatment

N/A

Clinical Study ID

NCT03408210
LouX01
  • Ages 8-65
  • All Genders

Study Summary

RATIONALE: Giving chemotherapy and total marrow and lymphoid irradiation before allogeneic hematopoietic cell transplant helps stop the growth of leukemia cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may achieve brand new hematopoietic recovery. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells, resulting in graft versus-host disease.

PURPOSE: This study is to evaluate the toxicity and efficacy of total marrow and lymphoid irradiation conditioning when given together with combination chemotherapy and allogeneic peripheral blood stem cell transplant in treating patients with myelodysplastic syndrome or acute leukemia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Myelodysplastic syndrome with excess blasts: Cytopenias, Unilineage or multilineagedysplasia, 5-19% blasts in bone marrow.

  2. Acute lymphocytic leukemia or acute myelogenous leukemia who are in first remission orsecond remission.

  3. Karnofsky performance status (KPS) >= 70%

  4. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry andfor six months following duration of study participation; should a woman becomepregnant or suspect that she is pregnant while participating on the trial, she shouldinform her treating physician immediately

  5. All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, DR)identical siblings who is willing to donate primed blood stem cells or a 10/10 allelematched unrelated donor; a single allele mismatch at A, B, C, DR or DQ and a killerimmunoglobulin-like receptor (KIR) mismatch at C will be allowed; all ABO blood groupcombinations of the donor/recipient are acceptable since even major ABOcompatibilities can be dealt with by various techniques (red cell exchange or plasmaexchange)

  6. A cardiac evaluation with an electrocardiogram showing no ischemic changes or abnormalrhythm and an ejection fraction of >= 50% established by multi gated acquisition scan (MUGA) or echocardiogram

  7. Patients must have a serum creatinine of less than or equal to 1.3 mg/dL or creatinineclearance > 80 ml/min

  8. Hepatic: bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT),Alkaline phosphatase (ALP) < 5 x upper limit of normal (ULN)

  9. Pulmonary function: Carbon Monoxide Diffusing Capacity corrected (DLCOcorr) > 50% ofnormal, (oxygen saturation [>92%] can be used in child where pulmonary function tests (PFT's) cannot be obtained)

  10. The time from the end last induction or re-induction attempt should be greater than orequal to 14 days

  11. All subjects must have the ability to understand and the willingness to sign a writteninformed consent

Exclusion

Exclusion Criteria:

  1. Diagnosed extramedullary leukemia

  2. Active uncontrolled infection at time of enrollment or documented fungal infectionwithin 3 months.

  3. Evidence of Human immunodeficiency virus (HIV) infection

  4. Prior myeloablative transplant within the last 6 months

  5. Prior radiation therapy that would exclude the use of TMLI

  6. Relapsed patients who have undergone autologous or allogeneic hematopoietic stem celltransplantation previously

Study Design

Total Participants: 191
Study Start date:
March 01, 2014
Estimated Completion Date:
August 31, 2022

Study Description

Patient receives preparative therapy including cyclophosphamide and total body irradiation (TBI) of 10 Gy or total marrow and lymphoid irradiation (TMLI) of 12-20 Gy, and starts immunosuppressive therapy using cyclosporine or tacrolimus, methotrexate-based prophylaxes, followed by peripheral blood stem cell transplantation and granulocyte colony-stimulating factor administration.

Connect with a study center

  • Affiliated Hospital to Academy of Military Medical Sciences (307 Hospital of PLA)

    Beijing, Beijing 100071
    China

    Active - Recruiting

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