Acute Lymphoblastic LeukemiaPhase 2MOHELNCT00368355
T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts
A Phase 2 study testing Ara-C, Cyclophosphamide and Campath-1H in people with Acute Lymphoblastic Leukemia and Non Hodgkins Lymphoma, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Subjects are being asked to participate in this study because treatment of their disease requires them to receive a stem cell transplant. Stem cells or "mother" cells are the source of normal blood cells and lead to recovery of blood counts after bone marrow transplantation (BMT). Read more about this study
- Who is it for?
- Ages Up to 55 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Non Hodgkins Lymphoma, Myelodysplastic Syndrome
- What is being tested?
- Ara-C, Cyclophosphamide and Campath-1H
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2000to Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Lack of suitable conventional donor (i.e. 5/6 or 6/6 related or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor
- Age less than or equal to 55 years of age
- Patients with high risk ALL in CR1 or ALL or high grade (stage III or IV) NHL after first relapse or with primary refractory disease or minimal residual diseases.
- Myelodysplastic syndrome
- Patients with high risk AML in CR1 or after first relapse or with primary refractory disease or minimal residual disease.
- CML
- Hemophagocytic lymphohistiocytosis (HLH), familial hemophagocytic lymphohistiocytosis (FLH), viral-associated hemophagocytic syndrome (VAHS), X-linked lymphoproliferative disease (XLP), Severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T- or NK-cell malignancy
- Donor cells should be collected and frozen before conditioning starts
Who cannot join
- Patients with a life expectancy (< / = 6 weeks) limited by diseases other than leukemia
- Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction < 25%)
- Patients with severe renal disease (i.e., creatinine clearance less than 40 cc/1.73 m^2)
- Patients with pre-existing severe restrictive pulmonary disease (FVC less than 40% of predicted)
- Patients with severe hepatic disease (direct bilirubin greater than 3 ug/dl or SGPT (serum glutamic-pyruvic transaminase) greater than 500 ug/dl)
- Patients with severe personality disorder or mental illness
Show all 9Show fewer
- Patients with a severe infection that on evaluation by the Principal Investigator precludes ablative chemotherapy or successful transplantation
- Patients with documented HIV positivity
- 'High risk' ALL or AML refers to those acute leukemias identified by the presence of specific biologic features, which predict high likelihood of failure to conventional chemotherapy. As biologic features of high risk disease evolve with improvement of conventional chemotherapy, it is not practical to define this indication with any further specificity. Therefore, high risk AML/ALL will be determined by the primary physician.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Houston Methodist Hospital
Houston, Texas, 77030
Texas Children's Hosptial
Houston, Texas, 77030
About this study
Official title: CD-34 Selection for Ex-vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts Receiving Intensive Conditioning
Subjects are being asked to participate in this study because treatment of their disease requires them to receive a stem cell transplant. Stem cells or "mother" cells are the source of normal blood cells and lead to recovery of blood counts after bone marrow transplantation (BMT). Unfortunately, there is not a perfectly matched stem cell donor (like a sister or brother) and the subject's disease is considered rapidly progressive and does not permit enough time to identify another donor (like someone from a registry list that is not their relative). We have, however, identified a close relative of the subject's whose stem cells are not a perfect match, but can be used. However, with this type of donor, there is typically an increased risk of developing graft-versus-host disease (GVHD), a high rate of transplant failure, and a longer delay in the recovery of the immune system.
GVHD is a serious and sometimes fatal side effect of stem cell transplant. GVHD occurs when the new donor cells (graft) recognizes that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs, primarily the skin, liver, and intestines. The number of occurrences and harshness of severe GVHD depends on several factors, including the degree of genetic differences between the donor and recipient, the intensity of the pre-treatment conditioning regimen, the quantity of transplanted cells, and the recipient's age. In recipients of mismatched family member or matched unrelated donor stem cell transplants, there is a greater risk of GVHD so that 70-90% of recipients of unchanged marrow will develop severe GVHD which could include symptoms such as marked diarrhea, liver failure, or even death.
In an effort to lower the occurrences and severity of graft-versus-host disease in patients and to lower the rate of transplant failure, we would like to specially treat the donor's blood cells to remove cells that are most likely to attack the patient's tissues. This will occur in combination with intense conditioning treatment that the patient will receive before the transplant.
Read the detailed description
To participate in this study, the subject will need to have a central line (a thin plastic catheter or tube that is placed during surgery into one of the large veins in the neck or chest).
Also before treatment can begin, we will test the subject's blood for viruses which can cause problems after the transplant.
Before treatment can begin, stem cells will be collected from the donor that has been selected as the best match for the subject. White blood cells will be collected from the donor. The cells will then be mixed with a special protein called a CD34 antibody that binds to the stem cells which will then be separated out from the white blood cells by a special machine called a CLINIMACs CD34 Reagent System in the laboratory. This is an investigational and experimental device which is not approved by the FDA. Although this device is not approved for use in this country, it has been in use for years and is approved in other countries. The stem cells will be collected and frozen before we start to give chemotherapy.
TREATMENT PLAN
To prepare the subject's body for transplantation, the subject will be given high dose chemotherapy (also called a conditioning treatment) for 8 days prior to the transplant as follows:
The subject will be given a drug called Ara-C in high doses through the central line every 12 hours starting 8 days before transplant (called day - 8) until 5 days before transplant (called day - 5). Starting one day after receiving the first Ara-C dose (day - 7), we will add a drug called cyclophosphamide once a day to the treatment for the next two days. This will be given in high doses (also through the central line). Also on day - 7, we will add a drug called MESNA. MESNA is used to decrease the side effects caused by cyclophosphamide. After the medication treatment is finished (day - 4), radiation treatment will be given to the entire body twice a day for 4 days. The chemotherapy and radiation treatment will last 8 days. If the subject has abnormal cells in the spinal fluid, 6 extra daily doses of radiation treatment may be given to the head. This would be done before any of the drugs are given and before the subject is admitted for transplant.
NOTE: Depending on the subjects health status, the doctor may decide the subject should not receive Ara-C. If this is a possibility, the doctor will discuss this with the subject.
On the second day of radiation (day -3), the subject will receive CAMPATH-1H as a daily 4-hour IV (intravenous, by vein). The subject will receive this infusion once a day for a total of three days. CAMPATH 1H is a special type of protein called an antibody, that works against certain types of blood cells. CAMPATH 1H is important because it stays active in the body for a long time after infusion, which means it may work longer at preventing GVHD symptoms.
The day after the radiation treatment is completed (day 0), the subject will receive the specially selected donor stem cells. Once in the bloodstream, the cells will go to the bone marrow and should begin to grow. If the subject is at risk for developing GVHD or if the subject begins to develop GVHD, the doctor will prescribe medicines to help prevent or treat this side effect. The doctor will describe these medicines at that time.
To learn more about the way the new cells are growing blood will be taken for research purposes at approximately 3 months, 6 months, 9 months, and a year after the transplant. On day 100, the subject will have the same tests/evaluations the subject has been experiencing since the transplant, however, the subject will also have a bone marrow aspirate (we take a sample of bone marrow to evaluate the disease and GVHD status). For patients who do not develop GVHD, they may have an additional bone marrow aspirate on day 180 (about 2 months after the previous one).
After day 365, the subject will be asked to return to the clinic once a year for evaluations. These evaluations will be similar to the ones the subject had on day 100.
- Conditions
- Acute Lymphoblastic Leukemia, Non Hodgkins Lymphoma, Myelodysplastic Syndrome, Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, Hemophagocytic Lymphohistiocytosis (HLH)
- Being tested
- Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation, Stem Cell Infusion
- Keywords
- haploidenticalstem cell transplant, acute lymphoblastic leukemia, Non Hodgkins Lymphoma, Myelodysplastic Syndrome, Acute myeloid leukemia, Chronic myelogenous leukemia, Hemophagocytic lymphohistiocytosis (HLH), Familial hemophagocytic lymphohistiocytosis (FLH), Viral-associated hemophagocytic syndrome (VAHS), X-linked lymphoproliferative disease (XLP)
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Lymphohistiocytosis, Hemophagocytic, Lymphoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ara-CDrug
Also called cytarabine
day-8 through day-5
3 g/m2 q 12 hours
CyclophosphamideDrug
Also called Cytoxan
day-7 and day-6
45 mg/kg
Campath-1HBiological
Also called Alemtuzumab
day-3 through day-1
Dosing for children:
5 - 15kg : 3mg IV in 30ml NS
15.1 - 30kg : 5mg IV in 50ml NS
>30 kg : 10mg IV in 100ml NS
Adults will receive 10mg IV in 100ml NS
Total Body IrradiationRadiation
day-4 through day-1
175 cGy x 2 at 24 cGy/min
Stem Cell InfusionProcedure or surgery
Stem cells are infused on day 0
| Study group | Role | What they receive |
|---|---|---|
| CLINIMACS Device | Experimental | Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device Receives: Drug: Ara-C; Drug: Cyclophosphamide; Biological: Campath-1H; Radiation: Total Body Irradiation; Procedure: Stem Cell Infusion |
| ISOLEX Device | Experimental | Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device Receives: Drug: Ara-C; Drug: Cyclophosphamide; Biological: Campath-1H; Radiation: Total Body Irradiation; Procedure: Stem Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engraftment Rate After Transplant
Percentage of participants with hematopoietic engraftment post-transplant. Engraftment is defined as the first day absolute neutrophil counts exceeded 0.5 X 10^9/ml.
Measured: 28 days
Secondary outcomes (4)
Early Post BMT Toxicities
Number of participants who experience organ failure or severe infections (defined as Grade III/IV by NCI CTC for Adverse Events (CTCAE), version 2.0)
Measured: 100 Days
Severe GVHD Rate
Percentage of participants with Grade III/IV acute GVHD. Severe GVHD is defined as Grade III/IV acute GVHD.
Measured: 100 Days
Patients With Acute GVHD
Number of participants with acute GVHD graded by the method of Przepiorka et al, which evaluates skin involvement, lower and upper GI, and liver function (bilirubin), each being graded in stages from 0 to 4, where 0 means no acute GVHD, and 4 is the highest stage of acute GVHD
Measured: First 100 Days
Patients With Chronic GVHD
Number of participants with chronic GVHD graded by the method of Przepiorka et al, which evaluates skin, joints, oral, ocular, hepatic, esophagus, GI, respiratory, platelet, and musculoskeletal involvement, in stages from 0 to 3.
Measured: Up to 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startApr 2000
- Primary completionNov 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Robert Krance, Baylor College of Medicine
- Investigators
- Robert A. Krance, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368355
- Sponsor's protocol ID
- H-8701-MOHEL
- Acronym
- MOHEL
- Status last verified
- Jan 2020
- First submitted
- 21 Sep 2005
- Last updated
- 21 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD-34 Selection for Ex-vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts Receiving Intensive Conditioning
- ClinicalTrials.gov ID
- NCT00368355
- Acronym / sponsor ID
- MOHEL / H-8701-MOHEL
- Conditions
- Acute Lymphoblastic Leukemia, Non Hodgkins Lymphoma, Myelodysplastic Syndrome, Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, Hemophagocytic Lymphohistiocytosis (HLH)
- Keywords
- haploidenticalstem cell transplant, acute lymphoblastic leukemia, Non Hodgkins Lymphoma, Myelodysplastic Syndrome, Acute myeloid leukemia, Chronic myelogenous leukemia, Hemophagocytic lymphohistiocytosis (HLH), Familial hemophagocytic lymphohistiocytosis (FLH)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Study start
- Apr 2000
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 24 Aug 2006 (estimated)
- Results
- Posted 21 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects are being asked to participate in this study because treatment of their disease requires them to receive a stem cell transplant. Stem cells or "mother" cells are the source of normal blood cells and lead to recovery of blood counts after bone marrow transplantation (BMT). Unfortunately, there is not a perfectly matched stem cell donor (like a sister or brother) and the subject's disease is considered rapidly progressive and does not permit enough time to identify another donor (like someone from a registry list that is not their relative). We have, however, identified a close relative of the subject's whose stem cells are not a perfect match, but can be used. However, with this type of donor, there is typically an increased risk of developing graft-versus-host disease (GVHD), a high rate of transplant failure, and a longer delay in the recovery of the immune system.
GVHD is a serious and sometimes fatal side effect of stem cell transplant. GVHD occurs when the new donor cells (graft) recognizes that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs, primarily the skin, liver, and intestines. The number of occurrences and harshness of severe GVHD depends on several factors, including the degree of genetic differences between the donor and recipient, the intensity of the pre-treatment conditioning regimen, the quantity of transplanted cells, and the recipient's age. In recipients of mismatched family member or matched unrelated donor stem cell transplants, there is a greater risk of GVHD so that 70-90% of recipients of unchanged marrow will develop severe GVHD which could include symptoms such as marked diarrhea, liver failure, or even death.
In an effort to lower the occurrences and severity of graft-versus-host disease in patients and to lower the rate of transplant failure, we would like to specially treat the donor's blood cells to remove cells that are most likely to attack the patient's tissues. This will occur in combination with intense conditioning treatment that the patient will receive before the transplant.
Detailed description
To participate in this study, the subject will need to have a central line (a thin plastic catheter or tube that is placed during surgery into one of the large veins in the neck or chest).
Also before treatment can begin, we will test the subject's blood for viruses which can cause problems after the transplant.
Before treatment can begin, stem cells will be collected from the donor that has been selected as the best match for the subject. White blood cells will be collected from the donor. The cells will then be mixed with a special protein called a CD34 antibody that binds to the stem cells which will then be separated out from the white blood cells by a special machine called a CLINIMACs CD34 Reagent System in the laboratory. This is an investigational and experimental device which is not approved by the FDA. Although this device is not approved for use in this country, it has been in use for years and is approved in other countries. The stem cells will be collected and frozen before we start to give chemotherapy.
TREATMENT PLAN
To prepare the subject's body for transplantation, the subject will be given high dose chemotherapy (also called a conditioning treatment) for 8 days prior to the transplant as follows:
The subject will be given a drug called Ara-C in high doses through the central line every 12 hours starting 8 days before transplant (called day - 8) until 5 days before transplant (called day - 5). Starting one day after receiving the first Ara-C dose (day - 7), we will add a drug called cyclophosphamide once a day to the treatment for the next two days. This will be given in high doses (also through the central line). Also on day - 7, we will add a drug called MESNA. MESNA is used to decrease the side effects caused by cyclophosphamide. After the medication treatment is finished (day - 4), radiation treatment will be given to the entire body twice a day for 4 days. The chemotherapy and radiation treatment will last 8 days. If the subject has abnormal cells in the spinal fluid, 6 extra daily doses of radiation treatment may be given to the head. This would be done before any of the drugs are given and before the subject is admitted for transplant.
NOTE: Depending on the subjects health status, the doctor may decide the subject should not receive Ara-C. If this is a possibility, the doctor will discuss this with the subject.
On the second day of radiation (day -3), the subject will receive CAMPATH-1H as a daily 4-hour IV (intravenous, by vein). The subject will receive this infusion once a day for a total of three days. CAMPATH 1H is a special type of protein called an antibody, that works against certain types of blood cells. CAMPATH 1H is important because it stays active in the body for a long time after infusion, which means it may work longer at preventing GVHD symptoms.
The day after the radiation treatment is completed (day 0), the subject will receive the specially selected donor stem cells. Once in the bloodstream, the cells will go to the bone marrow and should begin to grow. If the subject is at risk for developing GVHD or if the subject begins to develop GVHD, the doctor will prescribe medicines to help prevent or treat this side effect. The doctor will describe these medicines at that time.
To learn more about the way the new cells are growing blood will be taken for research purposes at approximately 3 months, 6 months, 9 months, and a year after the transplant. On day 100, the subject will have the same tests/evaluations the subject has been experiencing since the transplant, however, the subject will also have a bone marrow aspirate (we take a sample of bone marrow to evaluate the disease and GVHD status). For patients who do not develop GVHD, they may have an additional bone marrow aspirate on day 180 (about 2 months after the previous one).
After day 365, the subject will be asked to return to the clinic once a year for evaluations. These evaluations will be similar to the ones the subject had on day 100.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLINIMACS Device | Experimental | Drug: Ara-C, Drug: Cyclophosphamide, Biological: Campath-1H, Radiation: Total Body Irradiation, Procedure: Stem Cell InfusionSubjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device |
| ISOLEX Device | Experimental | Drug: Ara-C, Drug: Cyclophosphamide, Biological: Campath-1H, Radiation: Total Body Irradiation, Procedure: Stem Cell InfusionSubjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device |
Who may qualify
- Ages
- Up to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Lack of suitable conventional donor (i.e. 5/6 or 6/6 related or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor
- Age less than or equal to 55 years of age
- Patients with high risk ALL in CR1 or ALL or high grade (stage III or IV) NHL after first relapse or with primary refractory disease or minimal residual diseases.
- Myelodysplastic syndrome
- Patients with high risk AML in CR1 or after first relapse or with primary refractory disease or minimal residual disease.
Key exclusion criteria (9 listed)
- Patients with a life expectancy (< / = 6 weeks) limited by diseases other than leukemia
- Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction < 25%)
- Patients with severe renal disease (i.e., creatinine clearance less than 40 cc/1.73 m^2)
- Patients with pre-existing severe restrictive pulmonary disease (FVC less than 40% of predicted)
- Patients with severe hepatic disease (direct bilirubin greater than 3 ug/dl or SGPT (serum glutamic-pyruvic transaminase) greater than 500 ug/dl)
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 |
|---|---|---|
| Ara-CAlso: cytarabineday-8 through day-5 3 g/m2 q 12 hours | Drug | CLINIMACS Device, ISOLEX Device |
| CyclophosphamideAlso: Cytoxanday-7 and day-6 45 mg/kg | Drug | CLINIMACS Device, ISOLEX Device |
| Campath-1HAlso: Alemtuzumabday-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS >30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS | Biological | CLINIMACS Device, ISOLEX Device |
| Total Body Irradiationday-4 through day-1 175 cGy x 2 at 24 cGy/min | Radiation | CLINIMACS Device, ISOLEX Device |
| Stem Cell InfusionStem cells are infused on day 0 | Procedure or surgery | CLINIMACS Device, ISOLEX Device |
Primary outcome
Engraftment Rate After Transplant
Time frame: 28 days
Percentage of participants with hematopoietic engraftment post-transplant. Engraftment is defined as the first day absolute neutrophil counts exceeded 0.5 X 10^9/ml.
4 secondary outcomes
Early Post BMT Toxicities
Time frame: 100 Days
Severe GVHD Rate
Time frame: 100 Days
Patients With Acute GVHD
Time frame: First 100 Days
Patients With Chronic GVHD
Time frame: Up to 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert A. Krance, MD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ara-C, Cyclophosphamide and Campath-1H in people with Acute Lymphoblastic Leukemia and Non Hodgkins Lymphoma, run by Baylor College of Medicine at 2 sites in United States.
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 8 inclusion and 9 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 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Rate After Transplant (time frame: 28 days). 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 21 Jan 2020.