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Completed

NCT Number: NCT00109993

Campath-1H + FK506 and Methylprednisolone for GVHD

RATIONALE: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant.

PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant.

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Key information

Conditions

Breast Cancer Adnexal Diseases Blast Crisis Blood Protein Disorders Bone Marrow Diseases Breast Diseases Breast Neoplasms Burkitt Lymphoma Carcinogenesis Carcinoma Carcinoma, Ovarian Epithelial Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Chronic Myeloproliferative Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Epstein-Barr Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gestational Trophoblastic Disease Gestational Trophoblastic Tumor Gonadal Disorders Graft Versus Host Disease Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Hairy Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Neutrophilic, Chronic Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Male Urogenital Diseases Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Plasma Cell Neoplastic Processes Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Pregnancy Complications Pregnancy Complications, Neoplastic Primary Myelofibrosis Sezary Syndrome Skin Diseases Skin and Connective Tissue Diseases Testicular Diseases Testicular Germ Cell Tumor Testicular Neoplasms Trophoblastic Neoplasms Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mt. Sinai Medical Center, New York, United States

Loading trial locations.

About this study

OBJECTIVES:

Primary

  • Determine the 4-week rate of complete response in patients with severe acute graft-vs-host disease (GVHD) treated with alemtuzumab, tacrolimus, and methylprednisolone within 100 days after undergoing allogeneic stem cell transplantation.

Secondary

  • Determine the best response at 4 and 12 weeks in patients treated with this regimen.
  • Determine 6-month survival of patients treated with this regimen.
  • Determine the rate of infectious complications in patients treated with this regimen.
  • Determine rate of chronic GVHD in patients treated with this regimen.

OUTLINE: This is an open-label, single-blind, multicenter study.

Patients receive methylprednisolone IV on days 1-3 and then orally or IV on days 4-14; tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180, followed by a taper in the absence of chronic graft-vs-host disease; and alemtuzumab IV over 2 hours on days 4-6, 18, and 32. Treatment continues in the absence of unacceptable toxicity or the development of serious infection.

After completion of study treatment, patients are followed at 2 and 4 weeks.

PROJECTED ACCRUAL: A total of 9-34 patients will be accrued for this study within 8-12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of acute graft-vs-host disease (GVHD)
  • Clinical grade C or D disease
  • No grade C disease with single organ skin involvement
  • Has undergone allogeneic stem cell transplantation within the past 100 days
  • Absolute neutrophil count > 500/mm^3 (donor-derived [> 60% by peripheral blood lymphocyte chimerism analyses])
  • No development of GVHD after prior donor lymphocyte infusion
  • Must have received prior prophylactic cyclosporine or tacrolimus at the onset of acute GVHD

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • No serologic evidence of active hepatitis B or C infection

Renal

  • Creatinine ≤ 3.5 mg/dL
  • No requirement for dialysis

Cardiovascular

  • No requirement for vasopressors

Pulmonary

  • No requirement for a ventilator

Other

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • No known HIV positivity
  • No active uncontrolled infection
  • No other organ dysfunction

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Treatment and study plan

Alemtuzumab

Biological

alemtuzumab IV over 2 hours on days 4-6, 18, and 32

methylprednisolone

Drug

methylprednisolone IV on days 1-3 and then orally or IV on days 4-14

Tacrolimus

Drug

tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180, followed by a taper in the absence of chronic graft-vs-host disease

Primary outcomes

  1. Graft-vs-host disease response

    Time frame: 1, 2, 3, and 4 months

Secondary outcomes

  1. Incidence of serious infections by clinical, radiologic, and microbiologic assessments

    Time frame: 1,2,3, and 4 months

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
May 4, 2005
Registry last updated
Jun 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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