Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload

City of Hope

Status and phase

Terminated

Phase 2

Conditions

Stage IIIA Breast Cancer

Stage III Mantle Cell Lymphoma

Stage IV Marginal Zone Lymphoma

Chronic Neutrophilic Leukemia

Recurrent Adult Diffuse Small Cleaved Cell Lymphoma

Noncontiguous Stage II Grade 1 Follicular Lymphoma

Recurrent Ovarian Germ Cell Tumor

Noncontiguous Stage II Mantle Cell Lymphoma

Recurrent Grade 3 Follicular Lymphoma

Recurrent Marginal Zone Lymphoma

Stage III Grade 3 Follicular Lymphoma

Recurrent Grade 1 Follicular Lymphoma

Recurrent Mantle Cell Lymphoma

Stage I Multiple Myeloma

Stage III Adult Diffuse Mixed Cell Lymphoma

Noncontiguous Stage II Small Lymphocytic Lymphoma

Chronic Myelomonocytic Leukemia

Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)

Stage III Adult Diffuse Large Cell Lymphoma

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Stage III Adult Burkitt Lymphoma

Stage III Adult Diffuse Small Cleaved Cell Lymphoma

Recurrent Grade 2 Follicular Lymphoma

Recurrent Ovarian Epithelial Cancer

Recurrent Malignant Testicular Germ Cell Tumor

Stage III Multiple Myeloma

Stage III Marginal Zone Lymphoma

Refractory Hairy Cell Leukemia

Stage IV Adult Diffuse Mixed Cell Lymphoma

Stage IV Ovarian Epithelial Cancer

Stage IV Adult Hodgkin Lymphoma

Stage IIIB Breast Cancer

Stage III Ovarian Epithelial Cancer

Recurrent Adult Immunoblastic Large Cell Lymphoma

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Adult Lymphoblastic Lymphoma

Stage III Small Lymphocytic Lymphoma

Stage IV Adult Diffuse Large Cell Lymphoma

Poor Prognosis Metastatic Gestational Trophoblastic Tumor

Stage IV Adult Immunoblastic Large Cell Lymphoma

Noncontiguous Stage II Grade 2 Follicular Lymphoma

Secondary Myelodysplastic Syndromes

Disseminated Neuroblastoma

Stage IV Adult Burkitt Lymphoma

Stage IV Chronic Lymphocytic Leukemia

Stage II Ovarian Epithelial Cancer

Recurrent Adult Acute Myeloid Leukemia

Stage II Multiple Myeloma

Stage IV Small Lymphocytic Lymphoma

Recurrent Neuroblastoma

Stage IV Adult Diffuse Small Cleaved Cell Lymphoma

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue

Iron Overload

Splenic Marginal Zone Lymphoma

Chronic Eosinophilic Leukemia

Noncontiguous Stage II Marginal Zone Lymphoma

Adult Acute Myeloid Leukemia in Remission

Stage IV Adult Lymphoblastic Lymphoma

Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma

Blastic Phase Chronic Myelogenous Leukemia

Stage III Chronic Lymphocytic Leukemia

Stage III Adult Immunoblastic Large Cell Lymphoma

Recurrent Small Lymphocytic Lymphoma

Stage III Adult Hodgkin Lymphoma

Stage III Adult Lymphoblastic Lymphoma

Accelerated Phase Chronic Myelogenous Leukemia

Nodal Marginal Zone B-cell Lymphoma

Recurrent Adult Burkitt Lymphoma

Noncontiguous Stage II Adult Lymphoblastic Lymphoma

Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma

Recurrent Mycosis Fungoides/Sezary Syndrome

Noncontiguous Stage II Adult Burkitt Lymphoma

Chronic Phase Chronic Myelogenous Leukemia

Stage III Grade 1 Follicular Lymphoma

Stage III Grade 2 Follicular Lymphoma

Recurrent Adult Hodgkin Lymphoma

Stage IV Grade 2 Follicular Lymphoma

Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)

Previously Treated Myelodysplastic Syndromes

Relapsing Chronic Myelogenous Leukemia

Recurrent Adult Diffuse Mixed Cell Lymphoma

Refractory Chronic Lymphocytic Leukemia

Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma

Stage IIIC Breast Cancer

Stage IV Grade 3 Follicular Lymphoma

Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma

Adult Acute Myeloid Leukemia With Del(5q)

Stage III Malignant Testicular Germ Cell Tumor

de Novo Myelodysplastic Syndromes

Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)

Recurrent Adult Diffuse Large Cell Lymphoma

Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma

Adult Acute Lymphoblastic Leukemia in Remission

Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable

Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)

Noncontiguous Stage II Grade 3 Follicular Lymphoma

Stage IV Mantle Cell Lymphoma

Primary Myelofibrosis

Secondary Acute Myeloid Leukemia

Atypical Chronic Myeloid Leukemia, BCR-ABL Negative

Stage IV Grade 1 Follicular Lymphoma

Stage IV Breast Cancer

Treatments

Drug: deferasirox

Study type

Interventional

Funder types

Other

Identifiers

NCT01159067

09187

NCI-2010-01428

Details and patient eligibility

About

RATIONALE: Low dose deferasirox may be safe and effective in treating patients who have undergone hematopoietic stem cell transplant and have iron overload.

PURPOSE: This pilot clinical trial studies safety and tolerability of deferasirox in hematopoietic stem cell transplant recipients who have iron overload. Effect of low dose deferasirox on labile plasma iron is also examined.

Full description

PRIMARY OBJECTIVES:

I. To determine labile plasma iron (LPI) levels in iron overloaded patients after allogeneic Hematopoietic Stem Cell Transplantation (HSCT).

II. To determine safety and tolerability of low dose deferasirox in the post allogeneic HSCT setting.

SECONDARY OBJECTIVES:

I. To determine ability of deferasirox to suppress LPI in allogeneic HSCT patients with serum ferritin over 1500 ng/ml.

II. To determine prevalence of elevated LPI in allogeneic HSCT recipients with serum ferritin over 1500 ng/ml.

III. To determine ability of low dose deferasirox to lower serum ferritin during the treatment period.

IV. To correlate LPI with serum ferritin in allogeneic HSCT recipients with serum ferritin over 1500 ng/ml.

OUTLINE: Patients receive deferasirox at 10 mg/kg once daily for 6 months in the absence of unacceptable toxicity. Labile plasma iron will be measured at baseline and at weeks 4, 12, and 24. Side effects of deferasirox will be recorded.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

Patients must have undergone a matched related donor, matched unrelated donor or cord blood Hematopoietic Stem Cell Transplant (HSCT) over 6 months ago
Patients currently on Desferal (desferrioxamine) therapy will require a one day wash out prior to the first dose of study drug
Serum ferritin >= 1500 ng/mL on two occasions two weeks apart at screening; samples must be obtained in the absence of concomitant infection
Normal C-reactive protein level at screening
Patients must be red cell transfusion independent for 2 months prior to enrollment
Sexually active women must use an effective method of contraception, or must have undergone clinical documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months)
Written informed consent by the patient

Exclusion

Chronic hepatic GVHD with serum total bilirubin over 2 mg/dL
Known hypersensitivity to deferasirox
Serum creatinine above the upper limit of normal
AST or ALT > 200 U/L during screening
Clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive and ALT above the normal range)
History of HIV positive test result (ELISA or Western blot)
History of drug or alcohol abuse within the 12 months prior to enrollment
ECOG Performance Status > 2
Patients with a diagnosis of or history of clinically relevant ocular toxicity related to iron chelation
Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
Pregnancy (as documented in required screening laboratory test) or breast feeding
Patients who received treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days or are planning to receive other investigational drugs while participating in the study
Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative