Combined Haploidentical-Cord Blood Transplantation for Adults and Children

Multiple Myeloma Clinical Trial

Official title:

Combined Haploidentical-Cord Blood Transplantation for Adults and Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943800
• Other study ID #: 14736B
• Status: Completed
• Phase: N/A
• Start date: October 9, 2006
• Est. completion date: September 2018

Study information

• Verified date: January 2021
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to assess the rate of engraftment with combined haploidentical-cord blood transplantation. The secondary objective is to evaluate the incidence and severity of acute and chronic graft-versus-host disease (GVHD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

Patients will be eligible for this study if they have any one of the diseases that are known to be cured after allogeneic stem cell transplantation.

1. Relapsed or refractory acute leukemia (myeloid or lymphoid)

2. Acute leukemia in first remission at high-risk for recurrence

3. Chronic myelogenous leukemia in accelerated phase or blast-crisis

4. Chronic myelogenous leukemia in chronic phase

5. Recurrent or refractory malignant lymphoma or Hodgkin lymphoma

6. Chronic lymphocytic leukemia, relapsed or with poor prognostic features

7. Multiple myeloma

8. Myelodysplastic syndrome

9. Chronic myeloproliferative disease

10. Hemoglobinopathies

11. Aplastic anemia

Exclusion Criteria:

1. Zubrod performance status > 2

2. Life expectancy is severely limited by concomitant illness

3. Patients with severely decreased LVEF or impaired pulmonary function tests(PFT's)

4. Estimated Creatinine Clearance <50 ml/min

5. Serum bilirubin> 2.0 mg/dl or SGPT >3 x upper limit of normal

6. Evidence of chronic active hepatitis or cirrhosis

7. HIV-positive

8. Patient is pregnant

9. Patient or guardian not able to sign informed consent

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes

Intervention

Drug:
• Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG)
Fludarabine is given through the vein daily for 5 days. Melphalan is given through the vein daily for 2 days. ATG is given every day in the vein for four days.

Procedure:
• Stem Cell Transplant
Infusion of haploidentical donor, umbilical cord blood
• Stem Cells Collections
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.

Drug:
• Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)
Fludarabine is given through the vein daily for 5 days. Thiotepa is given through the vein daily for 2 days. ATG is given through the vein every other day for 4 days. TBI is given twice a day for 3 days.
• Fludarabine, Busulfan, and ATG
Fludarabine is given through the vein daily for 5 days. Busulfan is given through the vein daily for 4 days. ATG is given through the vein every other day for 4 days.

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (1)

Liu H, Rich ES, Godley L, Odenike O, Joseph L, Marino S, Kline J, Nguyen V, Cunningham J, Larson RA, del Cerro P, Schroeder L, Pape L, Stock W, Wickrema A, Artz AS, van Besien K. Reduced-intensity conditioning with combined haploidentical and cord blood t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Neutrophil Engraftment	Cumulative incidence of graft failure (neutrophil) by day 28 was reported. Patients who did not have neutrophil engraftment before death was considered as a competing risk. Failure to engraft was defined as lack of evidence of hematopoietic recovery (ANC <500/mm3 and platelet count < 20,000/mm3) by day +35, confirmed by a biopsy revealing a marrow cellularity < 5%. Graft failure was also defined as initial myeloid engraftment by day +35, documented to be of donor origin, followed by a drop in the ANC to < 500/mm3 for more than three days, independent of any myelosuppressive drugs, severe GVHD, CMV, or other infection.	Transplant (Day 0) through Day +28
Secondary	Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)	Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).; Chronic GVHD is assessed by NIH consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria. (See Citation: Filipovich AH et al); The incidence of patients with acute GVHD (Grade II-IV) was determined at 180 days. The incidence of Chronic GVHD by 2 years was reported	Up to 2 years
Secondary	Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years	We reported overall survival at 2 years and 5 years after transplant	up to 5 years