Selective T-Cell Depletion to Reduce GVHD (Patients) Receiving Stem Cell Tx to Treat Leukemia, Lymphoma or MDS - Study Results

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Selective T-Cell Depletion to Reduce GVHD (Patients) Receiving Stem Cell Tx to Treat Leukemia, Lymphoma or MDS

This study has been completed.

Study NCT00025662 Information provided by National Institutes of Health Clinical Center (CC)

First Received on October 11, 2001. Last Updated on December 9, 2011 History of Changes

Results First Received: April 20, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Graft vs Host Disease Myelodysplastic Syndromes Leukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Chronic Leukemia, Lymphocytic Lymphoma Lymphoma, Mantle-cell Lymphoma, Non-Hodgkin Hodgkin Disease
Interventions:	Drug: RFT5-SMPT-dgA Drug: Nexell Isolex system

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment dates: 9/21/01 to 11/14/05 Location: Quarternary referral institute

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 enrolled patients were not transplanted: one, because of donor refusal and the other because she was transplanted elsewhere

Reporting Groups

	Description
RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants	Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults

Participant Flow: Overall Study

	RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
STARTED	25
COMPLETED	22 ^[1]
NOT COMPLETED	3
Withdrawal by Subject	2
Technical failure of manipulation	1

[1]	One patient who received a transplant did not meet eligibility and was a special exemption.

Baseline Characteristics

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Reporting Groups

	Description
RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants	Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults

Baseline Measures

	RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
Number of Participants [units: participants]	22
Age [units: participants]
<=18 years	0
Between 18 and 65 years	13
>=65 years	9
Age [units: years] Mean ± Standard Deviation	63 ± 6.6
Gender [units: participants]
Female	9
Male	13
Region of Enrollment [units: participants]
United States	22

Outcome Measures

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1. Primary:

Treatment-related Mortality [ Time Frame: 100 days after stem cell infusion ]

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2. Secondary:

Overall Survival [ Time Frame: Dec 2011. ]

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3. Secondary:

Cumulative Non Relapse Mortality [ Time Frame: Dec 2011. ]

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4. Other Pre-specified:

Acute GVHD (Any Grade) Using the CIBMTR Grading System. [ Time Frame: 100 days from transplant ]

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5. Other Pre-specified:

Acute GVHD (Grade 3 or 4) Using the CIBMTR Grading System. [ Time Frame: 100 days from transplant ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: A. John Barrett
Organization: NHLBI
phone: 301-402-4170
e-mail: barrettjj@mail.nih.gov

Publications of Results:

Solomon SR, Mielke S, Savani BN, Montero A, Wisch L, Childs R, Hensel N, Schindler J, Ghetie V, Leitman SF, Mai T, Carter CS, Kurlander R, Read EJ, Vitetta ES, Barrett AJ. Selective depletion of alloreactive donor lymphocytes: a novel method to reduce the severity of graft-versus-host disease in older patients undergoing matched sibling donor stem cell transplantation. Blood. 2005 Aug 1;106(3):1123-9. Epub 2005 Apr 7.

Other Publications:

Barrett J, Solomon S. The transition from bench to bedside: lessons learned in the creation of a new T-cell product for the clinic. Cytotherapy. 2004;6(6):593-5.

Solomon SR, Tran T, Carter CS, Donnelly S, Hensel N, Schindler J, Bahceci E, Ghetie V, Michálek J, Mavroudis D, Read EJ, Vitetta ES, Barrett AJ. Optimized clinical-scale culture conditions for ex vivo selective depletion of host-reactive donor lymphocytes: a strategy for GvHD prophylaxis in allogeneic PBSC transplantation. Cytotherapy. 2002;4(5):395-406.

Mielke S, Solomon SR, Barrett AJ. Selective depletion strategies in allogeneic stem cell transplantation. Cytotherapy. 2005;7(2):109-15. Review.

Responsible Party:	National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:	NCT00025662 History of Changes
Obsolete Identifiers:	NCT00016484
Other Study ID Numbers:	010162, 01-H-0162
Study First Received:	October 11, 2001
Results First Received:	April 20, 2011
Last Updated:	December 9, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration