Leukemia, Myeloid, AcutePhase 1NCT00458250
Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H
A Phase 1 study testing Haploidentical hematopoietic stem cell transplantation, Busulfan and Cyclophosphamide in people with Leukemia, Myeloid, Acute and Leukemia, Lymphoblastic, Acute, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Many patients suffering various malignant and non-malignant diseases need hematopoietic stem cell transplantation from a healthy person. In the majority of cases there is no matched related or unrelated donor. Read more about this study
- Who is it for?
- Ages 2 to 50 years
- Conditions the study is for
- Leukemia, Myeloid, Acute, Leukemia, Lymphoblastic, Acute
- What is being tested?
- Haploidentical hematopoietic stem cell transplantation, Busulfan and Cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- Sep 2006to Feb 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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%
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- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hematology-Oncology & BMT Research Center
Tehran, Tehran Province, 14114
About this study
Official title: Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H
Many patients suffering various malignant and non-malignant diseases need hematopoietic stem cell transplantation from a healthy person. In the majority of cases there is no matched related or unrelated donor.
Some researchers have been performed transplantation from semi-matched (haploidentical) related donors with relatively good results.
Chinese researchers have been performed this kind of transplantation using CAMPATH-1H and their reports indicates good results.
Chinese populations have more homogenous genetic background than Iranians. In this project, we are going to study the feasibility of this method of haploidentical transplantation in Iranian patients.
Read the detailed description
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.
- Being tested
- Haploidentical hematopoietic stem cell transplantation, Busulfan, Cyclophosphamide, CAMPATH-1H, Cyclosporin A
- Keywords
- Hematopoietic Stem Cell Transplantation, Haploidentical, Hematologic Neoplasms, human, Bone Marrow, Granulocyte Colony-stimulating Factor, CAMPATH, Alemtuzumab, AML, ALL, 10. Eligibility
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haploidentical hematopoietic stem cell transplantationProcedure or surgery
BusulfanDrug
CyclophosphamideDrug
CAMPATH-1HDrug
Cyclosporin ADrug
MethotrexateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Engraftment one month after transplantation
Measured: Up to 30 days from transplantation
Secondary outcomes (1)
six months survival
Measured: Up to 180 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2007 (estimated)
- Study startSep 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Mohammadreza Ostadali, MD, Ph.D., Study director, Hematology-Oncology & BMT Research CenterArdeshir Ghavamzadeh, MD, Principal investigator, Hematology-Oncology & BMT Research CenterKamran Alimoghaddam, MD, Principal investigator, Hematology-Oncology & BMT Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458250
- Sponsor's protocol ID
- 418-A-1954
- Status last verified
- Nov 2008
- First submitted
- 7 Apr 2007
- Last updated
- 18 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H
- ClinicalTrials.gov ID
- NCT00458250
- Acronym / sponsor ID
- 418-A-1954
- Keywords
- Hematopoietic Stem Cell Transplantation, Haploidentical, Hematologic Neoplasms, human, Bone Marrow, Granulocyte Colony-stimulating Factor, CAMPATH, Alemtuzumab, AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Feb 2008 (actual)
- First posted
- 10 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many patients suffering various malignant and non-malignant diseases need hematopoietic stem cell transplantation from a healthy person. In the majority of cases there is no matched related or unrelated donor.
Some researchers have been performed transplantation from semi-matched (haploidentical) related donors with relatively good results.
Chinese researchers have been performed this kind of transplantation using CAMPATH-1H and their reports indicates good results.
Chinese populations have more homogenous genetic background than Iranians. In this project, we are going to study the feasibility of this method of haploidentical transplantation in Iranian patients.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haploidentical hematopoietic stem cell transplantation | Procedure or surgery | – |
| Busulfan | Drug | – |
| Cyclophosphamide | Drug | – |
| CAMPATH-1H | Drug | – |
| Cyclosporin A | Drug | – |
| Methotrexate | Drug | – |
Primary outcome
Engraftment one month after transplantation
Time frame: Up to 30 days from transplantation
1 secondary outcome
six months survival
Time frame: Up to 180 days after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammadreza Ostadali, MD, Ph.D. study director
Hematology-Oncology & BMT Research Center
Ardeshir Ghavamzadeh, MD principal investigator
Hematology-Oncology & BMT Research Center
Kamran Alimoghaddam, MD principal investigator
Hematology-Oncology & BMT Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Haploidentical hematopoietic stem cell transplantation, Busulfan and Cyclophosphamide in people with Leukemia, Myeloid, Acute and Leukemia, Lymphoblastic, Acute, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engraftment one month after transplantation (time frame: Up to 30 days from transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2008.