NCT01159067

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2011

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

May 29, 2019

Completed
Last Updated

June 18, 2019

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

July 6, 2010

Results QC Date

May 2, 2019

Last Update Submit

June 7, 2019

Conditions

Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Small Cleaved Cell LymphomaIron OverloadAccelerated Phase Chronic Myelogenous LeukemiaAdult Acute Lymphoblastic Leukemia in RemissionAdult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Atypical Chronic Myeloid Leukemia, BCR-ABL NegativeBlastic Phase Chronic Myelogenous LeukemiaChronic Eosinophilic LeukemiaChronic Myelomonocytic LeukemiaChronic Neutrophilic LeukemiaChronic Phase Chronic Myelogenous Leukemiade Novo Myelodysplastic SyndromesDisseminated NeuroblastomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiableNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Adult Burkitt LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Mixed Cell LymphomaNoncontiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaNoncontiguous Stage II Adult Immunoblastic Large Cell LymphomaNoncontiguous Stage II Adult Lymphoblastic LymphomaNoncontiguous Stage II Grade 1 Follicular LymphomaNoncontiguous Stage II Grade 2 Follicular LymphomaNoncontiguous Stage II Grade 3 Follicular LymphomaNoncontiguous Stage II Mantle Cell LymphomaNoncontiguous Stage II Marginal Zone LymphomaNoncontiguous Stage II Small Lymphocytic LymphomaPoor Prognosis Metastatic Gestational Trophoblastic TumorPreviously Treated Myelodysplastic SyndromesPrimary MyelofibrosisRecurrent Adult Acute Myeloid LeukemiaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Malignant Testicular Germ Cell TumorRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent NeuroblastomaRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRelapsing Chronic Myelogenous LeukemiaSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromesSplenic Marginal Zone LymphomaStage I Multiple MyelomaStage II Multiple MyelomaStage II Ovarian Epithelial CancerStage III Adult Burkitt LymphomaStage III Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Mixed Cell LymphomaStage III Adult Hodgkin LymphomaStage III Adult Immunoblastic Large Cell LymphomaStage III Adult Lymphoblastic LymphomaStage III Chronic Lymphocytic LeukemiaStage III Grade 1 Follicular LymphomaStage III Grade 2 Follicular LymphomaStage III Grade 3 Follicular LymphomaStage III Malignant Testicular Germ Cell TumorStage III Mantle Cell LymphomaStage III Marginal Zone LymphomaStage III Multiple MyelomaStage III Ovarian Epithelial CancerStage III Small Lymphocytic LymphomaStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Adult Burkitt LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Mixed Cell LymphomaStage IV Adult Diffuse Small Cleaved Cell LymphomaStage IV Adult Hodgkin LymphomaStage IV Adult Immunoblastic Large Cell LymphomaStage IV Adult Lymphoblastic LymphomaStage IV Breast CancerStage IV Chronic Lymphocytic LeukemiaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Grade 3 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Ovarian Epithelial CancerStage IV Small Lymphocytic Lymphoma

Keywords

HSCT, iron overload, deferasirox, labile plasma iron

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L)

    At baseline

Secondary Outcomes (3)

  • Number of Patients With LPI Below 0.5 Umol/L After Treatment

    Assessed through 6 months from the start of treatment

  • Number of Patients With Serum Ferritin Level Lower Than 1500 ng/mL After Treatment

    Assessed through 6 months from the start of treatment

  • Correlation of LPI With Serum Ferritin

    Assessed through 6 months from the start of treatment

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.

Drug: deferasirox

Interventions

deferasiroxDRUG

Given orally

Also known as: Exjade, ICL670
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Iron OverloadLeukemia, Myeloid, Accelerated PhaseCongenital AbnormalitiesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhaseMyeloproliferative DisordersLymphoma, B-Cell, Marginal ZonePrimary MyelofibrosisPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticLymphoma, T-Cell, CutaneousLymphoma, FollicularTesticular NeoplasmsLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeNeuroblastomaCarcinoma, Ovarian EpithelialLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellMultiple MyelomaBreast Neoplasms

Interventions

Deferasirox

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyelodysplastic-Myeloproliferative DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, T-CellEndocrine Gland NeoplasmsNeoplasms by SiteGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCarcinomaOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Neoplasms, FemaleLeukemia, B-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Vinod Pullarkat
Organization
City of Hope National Medical Center
vpullarkat@coh.org
626-256-4673

Study Officials

  • Vinod Pullarkat, MD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 9, 2010

Study Start

July 1, 2010

Primary Completion

August 9, 2011

Study Completion

August 9, 2011

Last Updated

June 18, 2019

Results First Posted

May 29, 2019

Record last verified: 2017-11

Locations

US(1)