Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant

Phase 2

Completed

• Conditions: MDS; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Leukemia; Lymphoma; Multiple Myeloma; Myelodysplastic/Myeloproliferative Diseases
• Interventions: Drug: Ganciclovir

• Registration Number: NCT00530218
• Lead Sponsor: City of Hope Medical Center

Brief Summary

RATIONALE: Antiviral drugs, such as ganciclovir, act against viruses. Giving ganciclovir by infusion and then by mouth may be effective treatment for cytomegalovirus that has become active after donor bone marrow transplant.

PURPOSE: This phase II trial is studying how well giving ganciclovir by infusion and by mouth works in treating patients with cytomegalovirus after donor bone marrow transplant.

Detailed Description

OBJECTIVES:

* To determine the feasibility of using oral ganciclovir (GCV) following induction with intravenous GCV in the setting of cytomegalovirus (CMV) reactivation after bone marrow transplantation.

OUTLINE: Blood cultures for cytomegalovirus (CMV) are obtained periodically after the planned bone marrow transplantation (BMT). Patients showing reactivation of CMV receive induction ganciclovir (GCV) IV twice a day on days 1-7. Patients then receive maintenance oral GCV three times a day for 5 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically during study for pharmacokinetic studies.

Study Timeline

• Study Start: 1999-03
• Study First Submitted: 2007-09-13
• Study First Submitted QC: 2007-09-13
• Study First Posted: 2007-09-17
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2015-07-08
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-25
• Last Update Submitted: 2017-10-25
• Results First Posted: 2017-12-02
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Undergoing allogeneic transplantation, including unrelated donor bone marrow transplantation (BMT) and/or allogeneic donor leukocyte infusion, for any indication
• Patients or their donors must have had a positive pre-BMT cytomegalovirus (CMV) antibody titer as measured by enzyme-linked immunosorbent assay (ELISA)

PATIENT CHARACTERISTICS:

• Able to comply with study requirements

Exclusion criteria:

• Signs or symptoms of documented CMV infection, including any positive CMV culture from any site and/or any suspected or documented CMV-associated clinical syndrome, at the time of study entry
• History of symptomatic CMV-associated clinical syndrome

PRIOR CONCURRENT THERAPY:

• Receiving concurrent investigational antiviral agents

PATIENT CHARACTERISTICS:

• History of hypersensitivity to ganciclovir or acyclovir

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Study Participants	Ganciclovir	Ganciclovir IV 5 mg/kg/bid x 7 days followed by Ganciclovir Oral 1000 mg tid 7 days per week x 5 weeks

Primary Outcome Measures

Name	Time	Method
Observation of Cytomegalovirus (CMV) in Blood as Measured by Either Blood Culture or Polymerase Chain Reaction (PCR) During the Course of Antiviral Treatment	Twice Weekly after day 21 post-transplant
Number of Participants With Adverse Events	From first ganciclovir positive test, after day 21 post-hematopoietic cell transplant	This will be measured by the number of the CMV+ participants with adverse events occurring when receiving oral GCV.
Compliance Rate Among Patients With CMV Reactivation	From first ganciclovir positive test to the end of the 6th week GCV therapy	CMV reactivation patients completed 6-week GCV therapy.

Trial Locations

Locations (1)

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States