Have you or your loved ones been diagnosed with acute lymphoblastic leukemia (all)?

You may be eligible to participate in a acute lymphoblastic leukemia (all) clinical trial.

Have you or your loved ones been diagnosed with acute lymphoblastic leukemia (all)? You may be eligible to participate in a acute lymphoblastic leukemia (all) clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Acute Lymphoblastic Leukemia (ALL) Clinical Trial in Chicago IL

NCT00619879 | Phase 3 | Interventional

Have you or your loved ones been diagnosed with acute lymphoblastic leukemia (all)?

You may be eligible to participate in a acute lymphoblastic leukemia (all) clinical trial.

Have you or your loved ones been diagnosed with acute lymphoblastic leukemia (all)? You may be eligible to participate in a acute lymphoblastic leukemia (all) clinical trial.

Recruiting

Male & Female

Up to 21

Years old

This study is looking to recruit 200 Participants

The purpose of this study is to show that myeloablative hematopoietic progenitor cell transplantation (HPCT) continues to offer acceptable disease-free survival for select patients requiring HPCT.

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Details for the study

Brief Title

Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies

Official Title

Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies

Brief Summary

The purpose of this study is to show that myeloablative hematopoietic progenitor cell<br /> transplantation (HPCT) continues to offer acceptable disease-free survival for select<br /> patients requiring HPCT.

Detailed Description

Myeloablative hematopoietic progenitor cell transplantation (HPCT) remains the standard of
care for patients requiring HPCT. The purpose of this study is to evaluate the morbidity and
mortality of myeloablative HPCT at Children's Memorial Hospital. It will also look to
determine the toxicity of a single conditioning regimen consisting of total body irradiation
(TBI), etoposide (VP-16), and Cyclophosphamide for patients with transplant eligible lymphoid
malignant conditions or with transplant eligible myeloid malignant conditions who are
receiving cord blood units, or to determine the toxicity of a single conditioning regimen
consisting of Busulfan and Cyclophosphamide for patients with transplant eligible myeloid
malignant conditions who are not receiving cord blood units.

Treatments and/or Procedures

Myeloablative chemotherapy regimen for lymphoid malignancies or cord blood unit recipients

Total Body Irradiation (TBI) 1200 cGy will be given on days -8,-7,-6 and -5 in eight sessions, delivering 150cGy in each session. Etoposide 1000 mg/m2 as a 24 hour continuous infusion started on day -4. Cyclophosphamide 60 mg/kg/day IV given over 1 hour daily on days -3, -2.

Myeloablative Chemotherapy Regimen for Non Cord Blood Unit Recipients with Myeloid Malignancies

Busulfan administration: For children >/= 4 years of age, Busulfan 0.8 mg/kg/dose will be given every 6 hours over days -8,-7, -6, and -5 for a total of 16 doses. For children < 4 years of age, Busulfan 1 mg/kg/dose will be given every 6 hours over days -8, -7, -6, -5 for a total of 16 doses. Pharmacokinetic analysis will guide dose modifications targeted to receive an average AUC of 800-1200 microMols*min for the 16 doses. Lorazepam (0.05 mg/kg) IV will be administered one half hour before the initial dose of Busulfan is given and every 6 hours through day -4. Etoposide 1000 mg/m2 as a 24 hour continuous infusion started on day -4. Cyclophosphamide 60 mg/kg/day IV given over 1 hour daily on days -3 and -2.

CNS radiation treatment for ALL with prior CNS disease patients

Patients with prior CNS disease over the age of 1 year will be treated with 600 cGy of cranial irradiation in addition to 1200 cGy of TBI. Patients diagnosed with ALL with CNS disease (at the time of diagnosis or relapse) < 1 year of age will receive CNS treatment as Intrathecal Methotrexate as follows: Infants ≤ 1 year of age at the time of Intrathecal Therapy will receive a dosing of 7.5 mg once a month for 6 months after transplant beginning at day +30 with an adequate white count Children 1-2 years of age at the time of Intrathecal Therapy will receive 8 mg once a month for 6 months after transplant beginning at day +30 with an adequate white count

Hematopoietic progenitor cell transplantation HPCT

Hematopoietic progenitor cells (HPCs) will be infused on day 0. Source of cells may be bone marrow, peripheral blood cells, or cord blood units, from matched related or unrelated donors.

Study Criteria

Inclusion Criteria:

  -  Malignant Disease

       -  Chronic myleogenous leukemia in chronic or accelerated phase

       -  Acute lymphoblastic leukemia (ALL)

            -  First remission high-risk ALL (Ph+, t( 4-11) infants).

            -  Second remission ALL, after a short first remission (<36 mos from Dx).

            -  3rd or greater remission ALL.

       -  Acute myelogenous leukemia (AML)

            -  First remission high risk acute nonlymphoblastic (ANLL) (as defined by
               cytogenetics), if a matched sibling donor is available.

            -  Initial partial remission AML (<20% blasts in the bone marrow).

            -  AML that is refractory to two cycles of induction therapy.

            -  Second or greater remission AML

       -  Myelodysplastic/Myeloproliferative Disease

            -  Juvenile Myelomonocytic Leukemia (JMML)

            -  Myelosplastic syndrome and/or pre-leukemia at any stage

       -  Lymphoma

            -  Relapsed lymphoma with residual disease that appears to be chemo-sensitive
               and non-bulky (<5 cm at largest diameter)

  -  Venous Access: Three lumens of central vascular access will be required for all
     patients entered on protocol due to the need for a dedicated line for continuous
     infusion cyclosporine.

  -  Informed Consent: The patient and/or the patient's legally authorized guardian must
     acknowledge in writing that consent to become a study subject has been obtained in
     accordance with the institutional policies approved by the U.S. Department of Health
     and Human Services.

  -  Patient organ function requirements:

       -  Adequate renal function: Serum Creatinine <~1.5 x normal, or Creatinine clearance
          of 70 mL/min/1.73 mE2 or an equivalent GFR as determined by the institutional
          normal range

       -  Adequate liver function: Total bilirubin <1.5 x normal; and SGOT (AST) or SGPT
          (ALT) <~2.5 x normal

       -  Adequate cardiac function: Shortening fraction of >/=27% by echocardiogram

       -  Adequate pulmonary function: FEV1/FVC >/=60% by pulmonary function test; for
          children who are uncooperative, no evidence of dysnpea at rest, or exercise
          intolerance, and must have a pulse oximetry >94% in room air

  -  Performance status: Lansky for children </= 16 years >/= 60; Karnofsky status for
     those > 16 years of age >/= 70

  -  Effective Contraceptive Use: Women of childbearing potential and sexually active males
     should use effective contraception while on study.

Exclusion Criteria:

  -  Patients who are pregnant or lactating

  -  Inability to find a suitable donor for the patient

  -  Patient is HIV-positive

  -  Patient has active Hepatitis B

  -  Disease progression or relapse prior to HPC infusion