Know Cancer

or
forgot password

Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H


Phase 1
2 Years
50 Years
Not Enrolling
Both
Leukemia, Myeloid, Acute, Leukemia, Lymphoblastic, Acute

Thank you

Trial Information

Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H


Haploidentical hematopoietic stem cell transplantation is a very important therapeutic
intervention for treatment of some genetic disorders and hematological malignancies.

In the majority of cases, there is no matched related or unrelated donor. Haploidentical
hematopoietic stem cell transplantation is a promising alternative for critical cases.

To avoid severe graft versus host disease (GVHD), two types of T cell depletion (TCD) had
been used: total TCD and partial TCD.

Total TCD has disadvantages such as increased rate of rejection and relapse, and increased
rate of infections due to delayed immune reconstitution.

Partial TCD has been done by in vivo and/or in vitro methods. In haploidentical
transplantation, donor partial TCD (ex vivo TCD) without recipient TCD increases the rate of
rejection and can not prevent severe GVHD successfully.

In vivo TCD by partial depletion of donor and recipient T cells has been done in
haploidentical transplantation with good results (to some extent inferior to full matched
transplantations) by using CAMPATH, ATG, etc.

Most of these studies have been performed in Chinese and Japanese populations that have more
homogenous genetic background than other populations.

In order to study the feasibility of this kind of transplantation in Iranian patients, we
defined a project to perform haploidentical hematopoietic stem cell transplantation by
using in vivo CAMPATH-1H.


Inclusion Criteria:



INCLUSION CRITERIA - RECIPIENT: (all of the following)

- Ages 5-50 years

- Acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL)

- Second remission (CR2) in standard risk patients or CR1 in cases with high-risk
features (poor cytogenetic changes or secondary to myelodysplastic syndrome)

- Unavailability of HLA identical related donor or matched unrelated donor.

- Unavailability of other therapeutic intervention that prolongs patient survival.

- Lack of active infection.

- No history of allergy to CAMPATH.

- For adults: Ability to comprehend the investigational nature of the study and provide
informed consent. For minors: Written informed consent from one parent or guardian..

- Social and intellectual competency of the patient and his/her family to follow
medical recommendations.

INCLUSION CRITERIA - DONOR:

- The donor must be haploidentical with the recipient: In the order of priority,
siblings who have an identical paternal HLA haplotype with the patient, offspring
(for female patients that do not have appropriate sibling), and mother.

- Possibly, it is better that the donor and recipient to be of same blood group and
sex..

- Possibly, it is better that female donors not to be multiparous.

- Weight greater than or equal to 18 kg.

- Age between 2 and 60 years old.

- For adults: Ability to comprehend the investigational nature of the study and provide
informed consent. For minors: Written informed consent from one parent or guardian
and informed assent: The process will be explained to the minor on a level of
complexity appropriate for their age and ability to comprehend.

- Negative two-way WBC crossmatch with the recipient.

Exclusion Criteria:

EXCLUSION CRITERIA - RECIPIENT: (ANY OF THE FOLLOWING)

- Major anticipated illness or organ failure incompatible with survival from
transplantation.

- Severe psychiatric illness. Mental deficiency sufficiently severe as to make
compliance with the transplantation procedure unlikely and making informed consent
impossible.

- Positive pregnancy test for women of childbearing age.

- HIV positive

- Active infection

- Left ventricular ejection fraction less than 40%

- AST/SGOT greater than 20 x ULN (CTCAE grade IV v3.0)

- Bilirubin greater than 10 x ULN (CTCAE grade IV v3.0)

- Creatinine greater than 6 x ULN (CTCAE grade IV v 3.0)

- Occurrence of allergy symptoms and signs during CAMPATH infusion. EXCLUSION CRITERIA
- DONOR: (ANY OF THE FOLLOWING)

- Pregnant or lactating

- Unfit to receive filgrastim (G-CSF) and undergo apheresis (abnormal blood counts,
history of stroke, uncontrolled hypertension)

- Sickling hemoglobinopathies including HbSS, HbAS, HbSC

- HBsAg or HIV positive

- Active infection

- CMV positive (for CMV negative recipients)

- Severe psychiatric illness. Mental deficiency sufficiently severe as to make
compliance with the BMT treatment unlikely and making informed consent impossible

- Contraindication to general anesthesia.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Engraftment one month after transplantation

Outcome Time Frame:

Up to 30 days from transplantation

Principal Investigator

Mohammadreza Ostadali, MD, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Hematology-Oncology & BMT Research Center

Authority:

Iran: Ministry of Health

Study ID:

418-A-1954

NCT ID:

NCT00458250

Start Date:

September 2006

Completion Date:

February 2008

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Leukemia, Lymphoblastic, Acute
  • Hematopoietic Stem Cell Transplantation
  • Haploidentical
  • Hematologic Neoplasms
  • human, Bone Marrow
  • Granulocyte Colony-stimulating Factor
  • CAMPATH
  • Alemtuzumab
  • AML
  • ALL
  • 10. Eligibility
  • Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location