Clinical trial · Interventional

Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT

Reduced Intensity Myeloablative Total Body Irradiation and Thymoglobulin Followed by Allogeneic Peripheral Blood Stem Cell Transplantation

NCT00709592CI-TRIAL-00035715completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

One of two different doses of thymoglobulin will allow bone marrow engraftment with minimal Graft-versus-Host Disease and allow adequate immune response to allow the transplanted stem cells to replace the tumor cells.

Conditions

Conditions (8)

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

Condition (as posted)	Mapped entity	Match	Confidence
Acute Myeloid Leukemia	Acute Myeloid Leukemia	CURATED_BROADER	0.80
Chronic Lymphocytic Leukemia	Chronic Lymphocytic Leukemia	ONTOLOGY_EXACT	0.98
Chronic Myelogenous Leukemia	Myeloid Leukemia	CURATED_BROADER	0.80
Hodgkin Lymphoma	Hodgkin Lymphoma	ONTOLOGY_EXACT	0.90
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Multiple Myeloma	Multiple Myeloma	CURATED_EXACT	0.92
Myelodysplastic Syndrome	Myelodysplastic Syndrome	CURATED_BROADER	0.80
Non-Hodgkin's Lymphoma	Non-Hodgkin Lymphoma	ALIAS	0.90

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Allogeneic PBSCT or BMT	Procedure	—	UNRESOLVED
Mycophenolate Mofetil	Drug	—	UNRESOLVED
Tacrolimus	Drug	—	UNRESOLVED
Thymoglobulin	Biological	—	UNRESOLVED
Total-Body Irradiation	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
ATG 1.7 mg/kg, TBI, transplant
description
(Rabbit-ATG;Thymoglobulin,Genzyme) ATG 5.1 mg/kg in three divided doses (1.7 mg/kg/d) given over three days (day -9 to -7) followed by 450 cGy TBI and tacrolimus plus MMF GVHD prophylaxis. Patients receive lower dose anti-thymocyte globulin IV on days -9 to -7. Patients undergo total-body radiation (TBI) twice daily (BID) on day -1 and once daily (QD) on day 0. Patients then undergo peripheral blood stem cells or bone marrow transplant on day 0. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: patients receive tacrolimus orally (PO) on days -2 to 90-120 with taper for 2 months, and mycophenolate mofetil (MMF) PO BID on days 0-30.
interventionNames
1. Biological: Thymoglobulin
2. Radiation: Total-Body Irradiation
3. Procedure: Allogeneic PBSCT or BMT
4. Drug: Tacrolimus
5. Drug: Mycophenolate Mofetil
type
EXPERIMENTAL
label
ATG 2.5 mg/kg/d, TBI, transplant
description
(Rabbit-ATG;Thymoglobulin,Genzyme) ATG 7.5 mg/kg in three divided doses (2.5 mg/kg/d) given over three days (day -9 to -7) followed by 450 cGy TBI and tacrolimus plus MMF GVHD prophylaxis. Patients receive higher dose anti-thymocyte globulin intravenously (IV) on days -9 to -7. Patients undergo total-body radiation (TBI) twice daily (BID) on day -1 and once daily (QD) on day 0. Patients then undergo peripheral blood stem cells or bone marrow transplant on day 0. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: patients receive tacrolimus orally (PO) on days -2 to 90-120 with taper for 2 months, and mycophenolate mofetil (MMF) PO BID on days 0-30.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 40 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

* Patients with hematological malignancies for which allogeneic stem cell transplantation indicated including non-Hodgkin lymphoma (NHL), multiple myeloma (MM), acute myeloid leukemia (AML), Hodgkin lymphoma (HD), chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), and myelodysplastic syndrome (MDS)
* Patients with HLA compatible related or unrelated stem cell donor, willing and able to serve as an allogenic HSC donor. Unrelated donors have to be matched at HLA-A, B, C and DRB1 loci. A single locus mismatch will be tolerated in the event a more closely matched donor is not available.
* Patients age \>/=40 to \</=70 with an ECOG performance status \< 2
* Patients between 18 and 40 years of age will be eligible only if they have co-morbidities precluding conventional allogeneic transplantation with full intensity myeloablative conditioning
* Adequate cardiac, pulmonary, renal and hepatic function for transplant
* Negative serology for HIV
* Negative serum pregnancy test
* Patients who have received therapeutic radiation to a localized field will be eligible, provided critical structure tolerance doses have not been exceeded
* Patients who have had prior myeloablative autologous transplant will be eligible

Exclusion Criteria:

* Evidence of uncontrolled viral, fungal, bacterial infection
* Evidence of active meningeal or CNS disease
* Prior therapy with rabbit ATG, prior treatment with equine ATG is allowed if more than 3 months ago
* Breast feeding mothers are excluded

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jul 21, 2008
Primary completion: Feb 15, 2014
Completion: Jun 28, 2017
First posted: Jul 3, 2008
Last update posted: Nov 9, 2018
Results first posted: Feb 12, 2015
Enrollment: 42 (actual)
Lead sponsor: Virginia Commonwealth University OTHER
Collaborators: Genzyme, a Sanofi Company
Keywords: total body irradiation, Allogeneic Peripheral Blood Stem Cell Transplantation, thymoglobulin

Data updated 22 days agoSource updated Nov 9, 2018source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.