Clinical trial · Interventional

Alemtuzumab and Glucocorticoids in Treating Newly Diagnosed Acute Graft-Versus-Host Disease in Patients Who Have Undergone a Donor Stem Cell Transplant

A Phase II Study to Evaluate Low-Dose Alemtuzumab as a Glucocorticoid-Sparing Agent for Initial Systemic Treatment of Acute Graft-Versus-Host Disease

NCT00410657CI-TRIAL-00003445completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Alemtuzumab and glucocorticoids, such as prednisone or methylprednisolone, may be an effective treatment for acute graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This phase II trial is studying how well giving alemtuzumab together with glucocorticoids works in treating newly diagnosed acute graft-versus-host disease in patients who have undergone donor stem cell transplant.

Conditions

Conditions (12)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Chronic Myeloproliferative Disorders	Myeloproliferative Neoplasm	ALIAS	0.90
Gestational Trophoblastic Tumor	Gestational Trophoblastic Tumor	ONTOLOGY_EXACT	0.98
Graft Versus Host Disease	—	UNRESOLVED	—
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Multiple Myeloma and Plasma Cell Neoplasm	—	UNRESOLVED	—
Myelodysplastic/Myeloproliferative Diseases	Myelodysplastic/Myeloproliferative Neoplasm	ALIAS	0.90
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
alemtuzumab	Biological	Alemtuzumab	ALIAS
flow cytometry	Other	—	UNRESOLVED
immunologic technique	Other	—	UNRESOLVED
methylprednisolone	Drug	—	UNRESOLVED
pharmacological study	Other	—	UNRESOLVED
prednisone	Drug	Prednisone	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Proportion of patients with methylprednisolone (MP)-equivalent glucocorticoid doses ≤ 0.75 mg/kg on day 28 after starting therapy for graft-versus-host disease (GVHD)

Secondary outcomes (10)

measure
Total cumulative dose of MP-equivalent treatment during the first 8 weeks after study entry
measure
Proportion of patients with complete response, measured weekly through day 56
measure
Incidence of secondary systemic therapy for acute GVHD
measure
Cumulative acute GVHD activity index score at day 56
measure
Incidence of chronic GVHD at 1 year
measure

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Newly diagnosed acute graft-versus-host disease (GVHD)

  * Grade IIB-IV disease
* Requires glucocorticoids for treatment of GVHD, as indicated by 1 of the following:

  * Initial treatment with prednisone or methylprednisolone at 2 mg/kg is indicated (in the judgement of the attending physician) by any of the following:

    * Severity of GVHD requires hospitalization
    * GVHD manifestations include symptoms other than anorexia, nausea, and vomiting
    * GVHD begins within 2-3 weeks after hematopoietic stem cell transplantation (HSCT)
    * GVHD manifestations progress rapidly from 1 day to the next before treatment
  * Initial treatment with prednisone or methylprednisolone at 1 mg/kg did not produce adequate clinical improvement within the first 4 days (in the judgement of the attending physician)
* Has undergone allogeneic HSCT with myeloablative conditioning

  * No nonmyeloablative conditioning or autologous HSCT
* No primary treatment of acute GVHD with methylprednisolone at any of the following doses:

  * More than 2 mg/kg/day at any time
  * 2 mg/kg/day for \> 72 hours
  * 1 mg/kg/day for \> 96 hours
* No presence of distinctive or diagnostic manifestations of chronic GVHD
* No relapsed, refractory, or secondary malignancy

PATIENT CHARACTERISTICS:

* Karnofsky performance status (PS) 20-100% OR Lanksy PS 20-100%
* Life expectancy ≥ 1 month
* Absolute neutrophil count ≥ 500/mm\^3
* Negative pregnancy test
* No Mini Mental State Exam score \< 24/30 or confusion (for patients \> 12 years of age)
* No history of type I hypersensitivity reaction to alemtuzumab or any of its components
* No increasing levels of viremia by serial quantitative viral plasma polymerase chain reaction assays
* No invasive viral or fungal disease that does not respond to appropriate antiviral or antifungal medications

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No systemic immunosuppression tapered or stopped for treatment of leukemic relapse or minimal residual disease

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment