Acute Myeloid LeukemiaPhase 1NCT02129582
Targeted Marrow Irradiation, Fludarabine Phosphate, and Busulfan Before Donor Progenitor Cell Transplant in Treating Patients With Hematologic Malignancies
A Phase 1 study testing total marrow irradiation, fludarabine phosphate and busulfan in people with Acute Myeloid Leukemia and Hematologic Malignancies, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of targeted marrow irradiation when given with fludarabine phosphate and busulfan before donor progenitor cell transplant in treating patients with hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia, Hematologic Malignancies, Acute Lymphocytic Leukemia
- What is being tested?
- total marrow irradiation, fludarabine phosphate and busulfan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2014to 5 Mar 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ineligible to receive full myeloablative conditioning regimen for allogeneic hematopoietic progenitor cell transplant due to age or comorbidities
- Patients must have histologically or cytologically diagnosis of hematologic malignancies with an indication for allogeneic hematopoietic progenitor cell transplantation, who are ineligible to receive a full ablative conditioning regimen as part of their transplantation, including:
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Non Hodgkin lymphoma
- Hodgkin lymphoma
Show all 24Show fewer
- Multiple myeloma
- Myelodysplastic syndrome
- Chronic lymphocytic leukemia
- Chronic myeloid leukemia:
- Myeloproliferative syndromes including myelofibrosis
- Complete remission is not necessary for enrollment in this protocol
- Patients must have an allogeneic hematopoietic progenitor cell donor (HPCT), either a matched sibling, mismatched (1 allele) sibling, or a matched unrelated donor (MUD) or a mismatched (1 allele) unrelated donor
- Previous hematopoietic progenitor cell transplantation is allowed; a minimum of 6 months should have elapsed from prior autologous hematopoietic progenitor cell transplantation and a minimum of 6 months should have elapsed since prior allogeneic hematopoietic progenitor cell transplantation; prior transplantation with conditioning regimens using total body irradiation is not allowed
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy of > 12 weeks, in the opinion of and as documented by the investigator
- Patients must have adequate hepatic, and renal function as defined below: there is no exclusion for the presence of cytopenias
- Total bilirubin ≤ 1.5 times the institutional upper limit of normal
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ 2.5 X institutional upper limit of normal
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 X institutional upper limit of normal
- Creatinine clearance (calculated by the Cockroft-Gault formula) ≥ 60 ml/min
- Pulmonary Function Tests (FEV1, FVC, DLCO) 40%.
- Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) from the time of study entry, for the duration of study participation and for 3 months after completing treatment; should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Prior non-hematologic treatment toxicities must be resolved to ≤ grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, with the exception of the following grade 2 toxicities: alopecia; dry skin; spleen disorders, hearing impairment; tinnitus; hypothyroidism; hyperthyroidism; endocrine disorders; blurred vision; cataracts; constipation; gastroesophageal reflux; fatigue; abnormal coagulation tests INR and/or aPTT; weight gain or weight loss; anorexia; glucose intolerance; hypoalbuminemia; hypokalemia; muscle weakness; dysgeusia; paresthesias; peripheral motor and/or sensory neuropathy; hot flashes; hypertension.
- Patients must not have received other investigational agents within 14 days of initiation of the conditioning regimen
- Patients with untreated brain metastases should be excluded from this clinical trial
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine and or busulfan or other agents used in this study
- Prior allogeneic hematopoietic progenitor cell transplantation
- Prior autologous hematopoietic progenitor cell transplantation if the conditioning regimen included total body irradiation
Show all 11Show fewer
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; this exclusion criterion does not include the underlying disease for which the patient is undergoing hematopoietic progenitor cell transplantation
- Pregnant or breastfeeding women are excluded from this study; breastfeeding should be discontinued
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
- Patients with a history of therapy with radiation therapy are excluded
- Due to technical limitations of TMI, patients must be no taller than 1.9 m (6 feet 4 inches), and no wider from elbow to elbow in the supine position than 60 cm.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Phase I Trial of Escalated Doses of Targeted Marrow Irradiation (TMI) Combined With Fludarabine and Busulfan as Conditioning Regimen for Allogeneic Hematopoietic Progenitor Cell Transplantation
This phase I trial studies the side effects and best dose of targeted marrow irradiation when given with fludarabine phosphate and busulfan before donor progenitor cell transplant in treating patients with hematologic malignancies. Targeted marrow irradiation is a type of specialized radiation therapy that delivers a high dose of radiation directly to the cancer cells, which may kill more cancer cells and cause less damage to normal cells. Giving targeted marrow irradiation and chemotherapy drugs, such as fludarabine phosphate and busulfan, before a donor progenitor cell transplant may help stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's progenitor cells. When the healthy progenitor cells from a donor are infused into the patient they may help the patient's bone marrow make progenitor cells, red blood cells, white blood cells, and platelets.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose of targeted marrow irradiation given in combination with fludarabine (fludarabine phosphate) and busulfan as conditioning regimen for allogeneic hematopoietic progenitor cell transplantation.
SECONDARY OBJECTIVES:
- To describe the toxicity profile of the conditioning regimen of targeted marrow irradiation (TMI), fludarabine and busulfan for allogeneic hematopoietic progenitor transplantation.
II. To describe the use of two techniques of delivering TMI, volumetric modulated arc therapy (VMAT) and TomoTherapy, on patient's computed tomography (CT) simulation images and describe differences in organ avoidance and target coverage, planning time, and treatment delivery time.
III. To determine the disease response status 100 days after allogeneic hematopoietic progenitor cell transplantation with the conditioning regimen of TMI, fludarabine and busulfan.
IV. To determine the rates of acute graft versus host disease after allogeneic hematopoietic progenitor cell transplantation with the conditioning regimen of TMI, fludarabine and busulfan.
OUTLINE: This is a dose-escalation study of TMI.
CONDITIONING: Patients undergo TMI twice daily (BID) on days -10 to -7. Patients also receive fludarabine phosphate intravenously (IV) over 1 hour on days -6 to -2 and busulfan IV or orally (PO) on days -5 and -4.
TRANSPLANT: Patients undergo allogeneic hematopoietic progenitor cell transplant on day 0.
GRAFT-VERSUS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive anti-thymocyte globulin IV on days -3 and -2, tacrolimus IV or PO beginning on day -1 for at least 6 months with taper beginning at 4 months, and methotrexate IV on days 1, 3, 6, and 11.
After completion of study treatment, patients are followed up at 100 days, 6 months, and 12 months.
- Conditions
- Acute Myeloid Leukemia, Hematologic Malignancies, Acute Lymphocytic Leukemia, Non Hodgkin Lymphoma, Hodgkin Lymphoma, Multiple Myeloma
- Being tested
- total marrow irradiation, fludarabine phosphate, busulfan, myeloid progenitor cell transplantation, anti-thymocyte globulin
- Medical subject headings
- Leukemia, Myeloid, Acute, Hematologic Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma, Myelodysplastic Syndromes, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total marrow irradiationRadiation
Undergo TMI
Also called 2-F-ara-AMP, Beneflur, Fludara
Given IV
busulfanDrug
Also called BSF, BU, Misulfan, Mitosan
Given IV or PO
myeloid progenitor cell transplantationProcedure or surgery
Also called MPCT
Undergo allogeneic hematopoietic progenitor cell transplant
anti-thymocyte globulinBiological
Also called ATG, ATGAM, lymphocyte immune globulin, Thymoglobulin
Given IV
tacrolimusDrug
Also called FK 506, Prograf
Given IV or PO
methotrexateDrug
Also called amethopterin, Folex, methylaminopterin, Mexate
Given IV
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (TMI, fludarabine, busulfan, allogeneic HPCT) | Experimental | CONDITIONING: Patients undergo TMI BID on days -10 to -7. Patients also receive fludarabine phosphate IV over 1 hour on days -6 to -2 and busulfan IV or PO on days -5 and -4.
TRANSPLANT: Patients undergo allogeneic hematopoietic progenitor cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive anti-thymocyte globulin IV on days -3 and -2, tacrolimus IV or PO beginning on day -1 for at least 6 months with taper beginning at 4 months, and methotrexate IV on days 1, 3, 6, and 11. Receives: Radiation: total marrow irradiation; Drug: fludarabine phosphate; Drug: busulfan; Procedure: myeloid progenitor cell transplantation; Biological: anti-thymocyte globulin; Drug: tacrolimus; Drug: methotrexate; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of targeted marrow irradiation defined as the dose level immediately below that in which greater than or equal to 2/6 subjects experience a dose limiting toxicity assessed using NCI CTCAE version 4.0
Measured: Up to day 32
Secondary outcomes (8)
Incidence of toxicities assessed using NCI CTCAE version 4.0
Measured: Up to day 32
Patient mortality
Measured: Day 100
Organ avoidance
Will be compared between the two techniques of delivering TMI (VMAT and TomoTherapy) using patients' CT simulation images.
Measured: Up to 12 months
Target coverage
Will be compared between the two techniques of delivering TMI (VMAT and TomoTherapy) using patients' CT simulation images.
Measured: Up to 12 months
Planning time
Will be compared between the two techniques of delivering TMI (VMAT and TomoTherapy) using patients' CT simulation images.
Measured: Up to 12 months
Treatment delivery time
Will be compared between the two techniques of delivering TMI (VMAT and TomoTherapy) using patients' CT simulation images.
Measured: Up to 12 months
Disease response status, assessed by standard criteria for the presence of relapse
Measured: Day 100
Rates of acute GVHD, graded and staged according to the Blood and Marrow Transplant Clinical Trials Network Manual of Operations
Measured: Up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study start5 Nov 2014
- Primary completion15 Mar 2019
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Molly Gallogly, MD, PhD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129582
- Sponsor's protocol ID
- CASE9Z13
- Status last verified
- May 2021
- First submitted
- 30 Apr 2014
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Escalated Doses of Targeted Marrow Irradiation (TMI) Combined With Fludarabine and Busulfan as Conditioning Regimen for Allogeneic Hematopoietic Progenitor Cell Transplantation
- ClinicalTrials.gov ID
- NCT02129582
- Acronym / sponsor ID
- CASE9Z13
- Conditions
- Acute Myeloid Leukemia, Hematologic Malignancies, Acute Lymphocytic Leukemia, Non Hodgkin Lymphoma, Hodgkin Lymphoma, Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 5 Nov 2014 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 2 May 2014 (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.
This phase I trial studies the side effects and best dose of targeted marrow irradiation when given with fludarabine phosphate and busulfan before donor progenitor cell transplant in treating patients with hematologic malignancies. Targeted marrow irradiation is a type of specialized radiation therapy that delivers a high dose of radiation directly to the cancer cells, which may kill more cancer cells and cause less damage to normal cells. Giving targeted marrow irradiation and chemotherapy drugs, such as fludarabine phosphate and busulfan, before a donor progenitor cell transplant may help stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's progenitor cells. When the healthy progenitor cells from a donor are infused into the patient they may help the patient's bone marrow make progenitor cells, red blood cells, white blood cells, and platelets.
Detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose of targeted marrow irradiation given in combination with fludarabine (fludarabine phosphate) and busulfan as conditioning regimen for allogeneic hematopoietic progenitor cell transplantation.
SECONDARY OBJECTIVES:
- To describe the toxicity profile of the conditioning regimen of targeted marrow irradiation (TMI), fludarabine and busulfan for allogeneic hematopoietic progenitor transplantation.
II. To describe the use of two techniques of delivering TMI, volumetric modulated arc therapy (VMAT) and TomoTherapy, on patient's computed tomography (CT) simulation images and describe differences in organ avoidance and target coverage, planning time, and treatment delivery time.
III. To determine the disease response status 100 days after allogeneic hematopoietic progenitor cell transplantation with the conditioning regimen of TMI, fludarabine and busulfan.
IV. To determine the rates of acute graft versus host disease after allogeneic hematopoietic progenitor cell transplantation with the conditioning regimen of TMI, fludarabine and busulfan.
OUTLINE: This is a dose-escalation study of TMI.
CONDITIONING: Patients undergo TMI twice daily (BID) on days -10 to -7. Patients also receive fludarabine phosphate intravenously (IV) over 1 hour on days -6 to -2 and busulfan IV or orally (PO) on days -5 and -4.
TRANSPLANT: Patients undergo allogeneic hematopoietic progenitor cell transplant on day 0.
GRAFT-VERSUS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive anti-thymocyte globulin IV on days -3 and -2, tacrolimus IV or PO beginning on day -1 for at least 6 months with taper beginning at 4 months, and methotrexate IV on days 1, 3, 6, and 11.
After completion of study treatment, patients are followed up at 100 days, 6 months, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (TMI, fludarabine, busulfan, allogeneic HPCT) | Experimental | Radiation: total marrow irradiation, Drug: fludarabine phosphate, Drug: busulfan, Procedure: myeloid progenitor cell transplantation, Biological: anti-thymocyte globulin, Drug: tacrolimus, Drug: methotrexate, Other: laboratory biomarker analysisCONDITIONING: Patients undergo TMI BID on days -10 to -7. Patients also receive fludarabine phosphate IV over 1 hour on days -6 to -2 and busulfan IV or PO on days -5 and -4. TRANSPLANT: Patients undergo allogeneic hematopoietic progenitor cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive anti-thymocyte globulin IV on days -3 and -2, tacrolimus IV or PO beginning on day -1 for at least 6 months with taper beginning at 4 months, and methotrexate IV on days 1, 3, 6, and 11. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patients ineligible to receive full myeloablative conditioning regimen for allogeneic hematopoietic progenitor cell transplant due to age or comorbidities
- Patients must have histologically or cytologically diagnosis of hematologic malignancies with an indication for allogeneic hematopoietic progenitor cell transplantation, who are ineligible to receive a full ablative conditioning regimen as part of their transplantation, including:
- Complete remission is not necessary for enrollment in this protocol
- Patients must have an allogeneic hematopoietic progenitor cell donor (HPCT), either a matched sibling, mismatched (1 allele) sibling, or a matched unrelated donor (MUD) or a mismatched (1 allele) unrelated donor
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Key exclusion criteria (11 listed)
- Prior non-hematologic treatment toxicities must be resolved to ≤ grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, with the exception of the following grade 2 toxicities: alopecia; dry skin; spleen disorders, hearing impairment; tinnitus; hypothyroidism; hyperthyroidism; endocrine disorders; blurred vision; cataracts; constipation; gastroesophageal reflux; fatigue; abnormal coagulation tests INR and/or aPTT; weight gain or weight loss; anorexia; glucose intolerance; hypoalbuminemia; hypokalemia; muscle weakness; dysgeusia; paresthesias; peripheral motor and/or sensory neuropathy; hot flashes; hypertension.
- Patients must not have received other investigational agents within 14 days of initiation of the conditioning regimen
- Patients with untreated brain metastases should be excluded from this clinical trial
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine and or busulfan or other agents used in this study
- Prior allogeneic hematopoietic progenitor cell transplantation
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 |
|---|---|---|
| total marrow irradiationUndergo TMI | Radiation | Treatment (TMI, fludarabine, busulfan, allogeneic HPCT) |
| fludarabine phosphateAlso: 2-F-ara-AMP, Beneflur, FludaraGiven IV | Drug | Treatment (TMI, fludarabine, busulfan, allogeneic HPCT) |
| busulfanAlso: BSF, BU, Misulfan, MitosanGiven IV or PO | Drug | Treatment (TMI, fludarabine, busulfan, allogeneic HPCT) |
| myeloid progenitor cell transplantationAlso: MPCTUndergo allogeneic hematopoietic progenitor cell transplant | Procedure or surgery | Treatment (TMI, fludarabine, busulfan, allogeneic HPCT) |
| anti-thymocyte globulinAlso: ATG, ATGAM, lymphocyte immune globulin, ThymoglobulinGiven IV | Biological | Treatment (TMI, fludarabine, busulfan, allogeneic HPCT) |
| tacrolimusAlso: FK 506, PrografGiven IV or PO | Drug | Treatment (TMI, fludarabine, busulfan, allogeneic HPCT) |
| methotrexateAlso: amethopterin, Folex, methylaminopterin, MexateGiven IV | Drug | Treatment (TMI, fludarabine, busulfan, allogeneic HPCT) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (TMI, fludarabine, busulfan, allogeneic HPCT) |
Primary outcome
Maximum tolerated dose of targeted marrow irradiation defined as the dose level immediately below that in which greater than or equal to 2/6 subjects experience a dose limiting toxicity assessed using NCI CTCAE version 4.0
Time frame: Up to day 32
8 secondary outcomes
Incidence of toxicities assessed using NCI CTCAE version 4.0
Time frame: Up to day 32
Patient mortality
Time frame: Day 100
Organ avoidance
Time frame: Up to 12 months
Target coverage
Time frame: Up to 12 months
Planning time
Time frame: Up to 12 months
Treatment delivery time
Time frame: Up to 12 months
Disease response status, assessed by standard criteria for the presence of relapse
Time frame: Day 100
Rates of acute GVHD, graded and staged according to the Blood and Marrow Transplant Clinical Trials Network Manual of Operations
Time frame: Up to 100 days
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 7 May 2021.
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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.
Molly Gallogly, MD, PhD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer 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 total marrow irradiation, fludarabine phosphate and busulfan in people with Acute Myeloid Leukemia and Hematologic Malignancies, run by Case Comprehensive Cancer Center at 1 site 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 24 inclusion and 11 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 7 May 2021. 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 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 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?
Maximum tolerated dose of targeted marrow irradiation defined as the dose level immediately below that in which greater than or equal to 2/6 subjects experience a dose limiting toxicity assessed using NCI CTCAE version 4.0 (time frame: Up to day 32). 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 7 May 2021.