Helical Tomotherapy, Fludarabine Phosphate, and Melphalan Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies



Status:Active, not recruiting
Conditions:Cancer, Blood Cancer, Lymphoma, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:7 - Any
Updated:10/11/2018
Start Date:June 2006
End Date:July 2019

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Allogeneic Stem Cell Transplant With a Novel Conditioning Therapy Using Helical Tomotherapy, Melphalan, and Fludarabine in Hematological Malignancies

RATIONALE: Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and HT
before a donor stem cell transplant helps stop the growth of cancer cells. It also helps 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 help the patient's bone marrow make
stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted
cells from a donor can make an immune response against the body's normal cells. Giving HT
together with fludarabine phosphate and melphalan before a transplant may stop this from
happening.

PURPOSE: This clinical trial studies helical tomotherapy (HT), fludarabine phosphate, and
melphalan followed by donor stem cell transplant in treating patients with hematologic
malignancies.

PRIMARY OBJECTIVES: I. To assess the feasibility in terms of toxicity and safety of HT in
combination with Fludarabine (fludarabine phosphate) and Melphalan as a preparative regimen
for allogeneic stem cell transplantation in patients with Hematological Malignancies: acute
lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and myelodysplastic syndromes
(MDS).

SECONDARY OBJECTIVES: I. To evaluate within the confines of this pilot study, incidence of
neutrophil and platelet engraftment, survival on day +180, the overall survival, and disease
free survival in patients with Hematological Malignancies: ALL, AML, and MDS.

II. To evaluate incidence of primary and secondary engraftment failure, incidence of relapse,
incidence of acute and chronic transplant related complications, including veno-occlusive
disease of the liver (VOD), organ toxicity, secondary malignancies, including
treatment-related myelodysplastic syndrome, and acute and chronic graft-versus-host disease
(GVHD), as well as post-transplant chimerism.

OUTLINE: PREPARATIVE REGIMEN*: Patients receive fludarabine phosphate intravenously (IV) on
days -7 to -3 and melphalan IV on day -2. Patients also undergo HT twice daily on days -7 to
-4.

TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day
0. NOTE: *Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for
GVHD prophylaxis.

After completion of study treatment, patients are followed up periodically for 2 years.

Inclusion Criteria:

- Recipient, or recipient's parents, or recipient's legal guardians must have signed a
voluntary, informed consent in accordance with institutional and federal guidelines

- Must have histopathologically confirmed diagnosis in one of the followed categories:

- AML

- MDS with intermediate or high-risk disease

- ALL

- Children and adults at any age with significant morbidity, as determined by the
primary bone marrow transplant (BMT) doctor (MD), and approved by the principal
investigator (PI)

- Able to lie supine in a full body cast for approximately 30 minutes, the anticipated
duration of each treatment session; for younger patients deep conscious sedation may
be required

- Performance status evaluated by Zubrod or Karnofsky (KPS) Performance Scales in
patients > 16 years or Lanksy Performance Scale in children =< 16 years must have a
score >= 70%

- Adequate cardiac function: cardiac ejection fraction > 50% by multi gated acquisition
scan (MUGA) scan and/or by echocardiogram

- Adequate pulmonary function: adults (older than 16 years): diffusing capacity of
carbon monoxide (DLCO) > 50%; for young children in whom pulmonary function tests
(PFT) are not applicable: assessment by a pediatrician or pulmonary consult

- Adequate renal function as demonstrated by: creatinine clearance or glomerular
filtration rate (GFR) > 60 cc/min (24 hour urine collection)

- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase
(SGPT) =< 5.0 times the institutional upper limits of normal

- Patients must have less than 15% peripheral blasts

- Pre-treatment tests must have been preformed within 30 days prior to initiation of
high-dose chemotherapy

- No other medical and/or psychosocial problems, which in the opinion of the primary
physician or principle investigator would place the patient at unacceptable risk from
this regimen

Exclusion Criteria:

- Patients with Acute Undifferentiated Leukemia (AUL), i.e. no lymphoid or myeloid
markers

- Previous radiation therapy to more than 20% of bone marrow containing areas, or to any
area exceeding 2000 cGy

- Patients with Fanconi Anemia

- Major medical or psychiatric disorders that would seriously compromise patient
tolerance of this regimen

- Human immunodeficiency virus (HIV) infection

- Evidence of Hepatitis B or C infection or evidence of cirrhosis

- Uncontrolled viral, bacterial or fungal infection

- Patients with recent (within 4 weeks) serious viral, fungal, or bacterial infection
are excluded

- Patients with radiographic changes indicating pulmonary disease, including but not
limited to: pulmonary nodules, infiltrates, pleural effusion are excluded unless
cleared by pulmonary biopsy showing no evidence for active pulmonary disease
We found this trial at
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Duarte, California 91010
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Duarte, CA
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